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Definition of excursion

Did you know.

In Latin, the prefix ex- means "out of" and the verb currere means "to run." When the two are put together, they form the verb excurrere , literally "to run out" or "to extend." Excurrere gave rise not only to excursion but also to excurrent (an adjective for things having channels or currents that run outward) and excursus (meaning "an appendix or digression that contains further exposition of some point or topic"). Other words deriving from currere include corridor , curriculum , and among newer words, parkour .

Examples of excursion in a Sentence

These examples are programmatically compiled from various online sources to illustrate current usage of the word 'excursion.' Any opinions expressed in the examples do not represent those of Merriam-Webster or its editors. Send us feedback about these examples.

Word History

Latin excursion-, excursio , from excurrere

circa 1587, in the meaning defined at sense 1a

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Dictionary Entries Near excursion

excursional

Cite this Entry

“Excursion.” Merriam-Webster.com Dictionary , Merriam-Webster, https://www.merriam-webster.com/dictionary/excursion. Accessed 24 Jan. 2024.

Kids Definition

Kids definition of excursion.

from Latin excursio, excursion- "a going out," from excurrere "to run out, make an excursion, extend," from ex- "out, forth" and currere "to run" — related to current

Medical Definition

Medical definition of excursion, more from merriam-webster on excursion.

Nglish: Translation of excursion for Spanish Speakers

Britannica English: Translation of excursion for Arabic Speakers

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Performing Investigations for Environmental Excursions

11 march 2010, united states.

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Pharma Beginners

Environmental Monitoring (EM) – New Approach Guide

  • Post author: pharmabeginers
  • Post published: January 13, 2021
  • Post category: cGMP / Micro Sop / Microbiology / QA Sop / QC Sop / SOPs / Sterile / Validation
  • Post comments: 2 Comments

This Guideline applies to routine Environmental Monitoring (EM) activities in classified manufacturing areas for viable and non-viable particulates, aseptic area personnel gown and glove samples, and for utility systems supplying those areas, such as compressed air, process gases, clean steam and water systems

ENVIRONMENTAL MONITORING (EM) PROGRAM

1.0   objective :.

  • This Global Quality Standard (GQS) provides the requirements for development and management of Environmental Monitoring (EM) Programs for sterile and non-sterile production.

2.0   SCOPE :

  • Guidance is provided for set-up of the program, criteria for selection of monitoring sites based on preceding qualification studies, Environmental Monitoring (EM) personnel training, frequency of monitoring, acceptance limits, methods for tracking, trending and reporting data, and investigation of exceeded limits and adverse trends.
  • Viable and non-viable particulates,
  • Aseptic area personnel gown and glove samples, and for
  • Utility systems supplying those areas, such as compressed air, process gases, clean steam and water systems.
  • Temperature,
  • Differential pressure,
  • Relative humidity, and
  • Non-viable particulate levels,
  • To verify acceptable conditions before beginning daily operations.
  • This Guideline for Environmental Monitoring (EM) provides guidance for response to environmental alarms following predefined alert/action limits and excursions during operations within classified manufacturing areas, utility systems supplying those areas, such as compressed air, process gases and water systems.
  • This Guideline provides guidance for monitoring and responding to alarms following predefined action/alert limits in refrigerators, incubators, stability chambers and other environmental chambers.

EXCLUSIONS:

  • This standard does not apply to-
  • Establishment of alarm (alert/action) limits for temperature, humidity or differential pressure,
  • Operation of environmental system controls, utility system operation or to setting up and operating Environmental Monitoring (EM) systems, Equipment, Facilities and Utilities Validation.
  • Requirements for routine operation of Environmental Monitoring (EM) systems are included in the SOP for Manufacturing Controls.
  • Certification of air classification, validation and routine testing and recertification of classified areas are defined in the Guideline for Equipment, Facilities and Utilities Validation .
  • Research & Development (R&D) functions are excluded from the scope of this GQS.

3.0   PROCESS DESCRIPTION – ENVIRONMENTAL MONETORING (EM)

General requirements for establishing an em program for sterile and non-sterile product manufacturing facilities:.

  • Classified areas, where required, shall be qualified as per the procedures outlined in the Guideline for- Equipment, Facilities and Utilities Validation .
  • Critical utility systems shall be qualified, including, but not limited to:
  • Clean steam,
  • Compressed air and gas systems, and
  • HVAC systems, as applicable to the specific facility.
  • Integrity of HEPA filters shall be tested and certified in classified areas of sterile and non-sterile facilities.
  • Sterile and non-sterile product manufacturing facilities shall implement procedures and training for routine and non-routine cleaning and sanitization of processing areas, including classified areas.
  • Sterile product manufacturing facilities shall also implement a program validation of sanitizer effectiveness, preferably with the inclusion of plant isolates as challenge organisms along with standard ATCC organisms .
  • Procedures shall be in place and effective for routine operation, maintenance, and calibration of equipment used to perform environmental sampling and testing at all facilities.
  • Equipment used for Environmental Monitoring (EM) must be calibrated and validated before use.
  • Refer to Attachment I for gowning qualification and the training and certification process requirements for personnel working in aseptic manufacturing areas.
  • Media for Environmental Monitoring (EM) shall be qualified and procedures in place for media preparation, sterilization, growth promotion, addition of antibiotic neutralizing agents (where applicable), sterility checks (pre-incubation), release, storage and disposal at all facilities that prepare or purchase prepared media for Environmental Monitoring (EM).
  • If the routine environmental monitoring sampling is performed by non- microbiologist personnel (e.g. operators from production) .

The following system shall be in place and documented:

  • Formal delegation program & documentation
  • Training program for environmental monitoring
  • Quality oversight evaluation
  • Environmental Monitoring (EM) procedures shall be current and effective, for sterile and non-sterile product facilities, and include:
  • Sampling plans, including frequency, location and methodology, graphic maps of sample locations, and sample frequency at each location.
  • Methods for handling and sanitizing documentation within aseptic areas, including sampling maps, forms and procedures.
  • Operation, calibration, and maintenance of Environmental Monitoring (EM) sample and test equipment.
  • Sanitization and transfer of Environmental Monitoring (EM) sampling equipment and utensils into and within aseptic processing areas.
  • Sampling procedures and methods for viable and non-viable particulates, as appropriate.
  • Laboratory procedures for sample handling, testing, data interpretation, storage, and recordkeeping.
  • Procedures for interpreting Environmental Monitoring (EM) media plates from powder filling operations shall include criteria for discrimination of microbial colonies versus powder on the media surface.
  • Setting alert and action levels and periodic reevaluation of the same based on trends.
  • Microbial identification in compliance with the Guideline for  Identification of Organisms .
  • Reporting and investigating out-of-specification Environmental Monitoring (EM) results and adverse trends and effectiveness verification of corrective action. (Refer to Guideline for Handling of Out-of-Specification (OOS) Results).
  • Verification of environmental conditions before beginning daily operations.
  • Environmental Monitoring (EM) Data trending and reporting.

Training Personnel:

  • Personnel that perform Environmental Monitoring (EM) sampling and testing shall be trained to current procedures for Training Management .
  • Environmental Monitoring (EM) sampling personnel entering classified areas shall be trained to procedures that govern required hygiene, gowning, and access requirements.

Environmental Monitoring (EM) Requirement in Sterile Manufacturing Facility :

  • Personnel performing Environmental Monitoring (EM) in sterile product facilities shall be trained and qualified to work in classified areas, including aseptic processing areas, and have been qualified for aseptic gowning.
  • Personnel performing Environmental Monitoring (EM) shall be trained and qualified to perform the following sampling processes for viable and non-viable particulates:

Viable particulate monitoring:

  • Active air samples
  • Passive air samples – Settle plates
  • Surface contact plates
  • Surface swabs
  • Personnel gown and glove contact plates

Non-viable particulate monitoring:

  • Continuous monitoring with a computerized data collection system
  • Discrete samples using portable particle counters with local printouts or data storage.

Aseptic processing personnel qualification requirements:

  • All personnel that enter the aseptic processing area, including those that only enter periodically and outside personnel approved by Quality, shall be qualified through a formal training program .
  • Assessment of their ability to consistently perform aseptic gowning shall be qualified initially and at least semi-annually (each 6-months) using contact-plate samples from gowns and gloves.
  • Attachment I contains training and certification requirements and Attachment II provides aseptic technique training guidelines. Site training programs shall include requirements from both attachments.
  • Personnel access o aseptic processing areas shall only be granted after successful completion of aseptic processing training and certification.

SELECTION OF SAMPLE SITES FOR CLASSIFIED AREAS IN STERILE PRODUCT FACILITIES:

  • Sample site locations shall be determined during initial startup and commissioning of classified areas using risk analysis.

Sample sites shall be based on the risk for product contamination:

  • Perform risk analysis during initial establishment of the Environmental Monitoring (EM) Program, when changes to the process, practices, or environment occur, and during investigation into excursions and adverse trends that may impact product quality. (Refer to Attachment III for Example of Risk Assessment Template for Sterile Products).
  • Determine locations for air and surface sampling based on the risk for product contamination.
  • High risk areas may include locations in proximity of the exposed product, containers, closures, and product-contact surfaces.
  • Evaluate activities, practices, and materials that present a potential risk for contamination of the environment where product and primary packaging components are exposed.

Product-contact surface contamination shall be evaluated to assess potential risk factors that may include, but are not limited to:

  • Frequency and duration of human activities and interventions.
  • Sterility of components and product-contact surfaces.
  • Air flow characteristics and differential pressures.
  • Impact of process equipment and operator movement / activity on unidirectional air flow.
  • Efficiency of the barrier and other control systems designed to protect product
  • Sites or processes in which microbial contamination would most likely have an adverse effect on product quality.
  • Sites that represent the most inaccessible or difficult areas to clean and disinfect.
  • Understanding of modes of microbial dispersal in the environment and related causes and sources of microbial load.
  • Risk of monitoring activity for contamination of product.
  • Review of historical data for high risk area.

Personnel, materials, and process flow.

  • Proximity to exposed components, product, or product-contact surface.
  • Potential of critical zone contamination from adjacent lower-grade areas.
  • Potential for interventions, including the manipulations that may be associated with Environmental Monitoring (EM), and which may adversely affect the critical zone environment.
  • Evaluate airflow visualization (“smoke”) studies under dynamic conditions to assess risk of airflow disruption within critical zones and to assist in determining potential sites for viable and non-viable particulate monitoring.
  • Rationale for selection of all sample sites shall be prepared and included in the area qualification report. Risk assessments shall be included in the See Attachments III and IV for risk assessment templates.
  • The minimum number of sample sites in a classified area shall be determined from Table 1, as published in ISO 14644-1:2015(E),
  • Table A.1. The number of sampling sites recommended represents the minimum. Based on risk assessment, additional sites may be needed.
  • Select sample sites, so that they evaluate the impact of personnel movement and work within the area, particularly during interventions and manipulations within critical zones where sterile product, containers, closures, and product-contact surfaces are exposed to personnel.
  • Active air samples collect a large volume of air in a short period of time, and could disrupt air flow,
  • Therefore the location and timing of sampling shall be considered to avoid risk of this disruption.
  • If the risk of airflow disruption from active air samplers is determined to be unacceptable in a critical location, settling plates shall be considered as an alternate monitoring method at that location.

Table 1: Sample Locations Related to Clean Rooms: Total Particulate Count

Surface monitoring locations shall be selected to:.

  • Assess microbial load on product-contact (equipment) and non-contact surfaces (floors, walls, benches, and non- product contact equipment).
  • Product-contact surface monitoring shall only be performed at the conclusion of critical operations in aseptic manufacturing environments to avoid contamination of the surface during monitoring.
  • Select non-product contact surface monitoring locations to assess the efficacy of cleaning/sanitizing/disinfecting practices within the aseptic processing area, see Table 2.
  • Table 2 lists example sample sites.
  • The number of sample sites and locations shall be based on documented risk assessments.

Table 2: Example Viable Monitoring Sites (for reference only)

Sample frequency in sterile product facilities:.

  • Sample frequency for aseptic processing environments shall be defined in written procedures.
  • Table 3 lists specific functions typical in each Graded area for sterile product manufacturing.
  • Table 4 lists minimum frequencies to be implemented at each site based on the most frequent sampling recommended in the referenced guidance document.
  • Environmental Monitoring (EM) sampling in aseptic processing isolators, including sterility test isolators, is listed in Table 5
  • The only guidance for sample frequency in grade D environments is from EU Annex 1, PIC/S and WHO Annex 4 where frequency should be risk based, see Table 3.
  • Although sampling frequency is not specified, risk of contamination carry-over to cleaner areas from grade D, ISO 5 areas is greater in aseptic manufacturing facilities than in non-aseptic facilities.
  • Based on the higher risk, airborne viable and non-viable particulates should be sampled regularly to provide assurance that contamination remains Sampling on at least a monthly basis is recommended when the area is in use.

Table 3: Classified Areas for Specific Functions in sterile product facilities

Table 4: minimum environmental monitoring (em) sample frequency requirements/ guidance, table 5: usp <1116> sample frequency recommendations for isolators, setting alert    and    action    limits    for    sterile    product facilities:.

  • Appropriate alert and action limits shall be set for total particulate and microbiological monitoring.
  • Site procedures shall be in place for investigation and corrective actions when limits are exceeded, or where there are indications of an adverse trend.
  • For Grade A environments, where viable counts are expected to approach 0 CFU, and only action level is required because there is no meaningful difference between alert and action levels.
  • Refer to Tables 6 and 7 for total particulate and viable particulate requirements stated in the EU Annex
  • “The site’s alert and action levels may be tighter than those recommended in Annex 1 based on historical data, and should be the result of reasonable performance assessment after periodic and regular review of the data”.
  • PDA TR13 provides several approaches to setting limits depending on the distribution of viable particulates.

Cut-off Value Approach:

  • All the test data for a particular site, or group of similar sites, are arranged in a histogram and the alert and action levels are set at values whose monitoring results are, respectively, 1% and 5% higher than the level selected.
  • Other percentiles may be used in establishing levels.
  • A variation is to take the last 100 monitoring results and use the 95th and 99th percentile values as the alert and action levels.

Normal Distribution Approach:

  • The mean and standard deviation of the data are calculated and the alert and action levels are set at the mean plus two (2) and three (3) times the standard deviation, respectively.
  • This approach is only used for high counts and when the data is normally distributed.
  • A Poisson distribution is used for low counts.

Non-Parametric Tolerance Limit Approach:

  • As EM data, especially in clean rooms, is typically not normally distributed (i.e., favors lower counts and/or zero counts),
  • A non-parametric Tolerance Limits approach to setting alert and action levels are recommended.
  • These limits allow assertion with confidence at least 95% (K=0.95) that 100(P) or 99% of a population lies below the value, depicted by the stated action limits, for the respective For Distribution- Free Tolerance Limits, Minimum Sample Size are N=60 for 95/95 (Alert Limit) and N=300 for 95/99 (Action Limits).

Table 6: Maximum Total Particulates from EU Annex 1.

Table 7: maximum viable particulates from eu annex 1., excursion and recovery rates of environmental monitoring (em) results:.

  • Excursion and recovery rates are related, but different measures of the microbial quality of the environment.
  • Once alert and action levels are derived, the excursion rate measures the number of samples exceeding the defined alert and action levels.
  • Recovery rates measure the overall microbial recovery (percent of samples with growth) in a given classified area, regardless of actual colony count.
  • Though alert and action levels have been eliminated from USP <1116> in favor of recovery rates, each site shall monitor both excursion rate and recovery rate because official regulatory guidance from the EU and US still retain GMP requirements for alert and action levels, see Tables 7 and 8.
  • Predefined excursion rates shall be developed from trend analysis and each site shall develop recovery rates for each classified area.
  • Table 8 lists USP <1116> recommended initial recovery rates that may be assigned for new aseptic processing areas.
  • If site recovery rates have already been developed for similar areas, then it is acceptable to continue using those rates.

Table 8: Suggested Initial Contamination Recovery Rates in Aseptic Environments.

Environmental Monitoring (EM) - Chart

ROUTINE ENVIRONMENTAL MONITORING (EM) IN STERILE    PRODUCT MANUFACTURING FACILITIES:

  • EM shall be performed during all aseptic manufacturing operations, including aseptic process simulations (media fills).
  • In addition, during media fills, duplicate plates shall be incubated
  • Active Air Sampling:
  • Active air samples are collected via suitable air sampling The device shall be qualified, calibrated, and properly sanitized/sterilized for use in classified areas.
  • Operation, calibration, and maintenance of the device shall follow manufacturer’s recommendations.
  • Devices may be located directly in the clean zone or remotely with a suitable sampling nozzle and tubing.
  • When remote sampling is performed, minimize the length of tubing and the number and angle of bends to avoid under recording of viable particulates.
  • Internal diameter of tubing must be such to provide air flow within the vendor’s specified range.
  • A single medium type or separate media for bacteria and fungi may be used.
  • Care must be exercised when placing  the agar medium on the sampling device to avoid contamination.
  • During room classification, sample volumes not less than 1 m 3 are required.
  • The volume of air sampled  for routine monitoring shall be qualified.

Passive Air Sampling – Settle Plates:

  • Non-selective agar, such as Soybean Casein Digest Agar, in 90 mm plates shall be standard for settle plates.
  • Other media may be used with justification.
  • Settle plates shall not exceed an exposure time of four hours.
  • Validation that four hours is appropriate shall be performed by challenging exposed plates with low levels of challenge organisms that are appropriate for the media.
  • For processes that extend beyond the validated exposure time, additional (new) plates shall be used.

Surface Sampling:

  • Each surface sample location shall be evaluated for geometry, e.g. curved, flat, textured, etc., and presence of sanitizing agents or other potentially inhibitory substances.
  • Agar media used for surface sampling shall be qualified for recovery of low levels of standard challenge organisms and expected environmental organisms
  • Appropriate neutralizing agents may be added to the agar or rinse or diluent when sampling surfaces that have been chemically
  • For examples of neutralizing agents for various classes of disinfecting agents see Table 9.
  • The efficacy and toxicity of neutralizing agents must be evaluated against the disinfectants used in the environment and the classes of organisms that may be present.

Methods for sampling surfaces for microbial contamination:

  • Flat surfaces and large curved surfaces that allow for good contact of the agar surface should be sampled using contact plates (RODACS),
  • But may be sampled using For contact plate sampling, remove the lid and press the agar surface against the surface with a gentle rocking motion to ensure contact of the surface with maximum agar area.
  • Irregular surfaces require a swab method or flexible agar film device.
  • Swabs are typically moistened with sterile water, peptone, buffer or transport media and a defined surface area, typically 25 cm2 (ca. 2 in X 2 in) is swabbed.
  • The sample may be directly plated or placed in a transport medium for later testing in the Microbiology Lab.
  • Transport media contains constituents that permit the organism to retain its viability without allowing proliferation.
  • Use of transport medium is recommended as it allows for a more accurate quantitative result.

Sanitization Procedure after surface monitoring:

  • Media residue should be removed from the sample site immediately after taking the imprint using an appropriate disposable wipe or swab impregnated with a suitable sterile disinfectant (e.g. sterile non-shedding disinfectant swab or wipe with sterile 70% Isopropyl Alcohol).
  • Otherwise the nutrient could create favorable conditions for microbial growth.
  • Rinse methods shall be used for evaluating areas that are difficult to sample by contact plate or swabs,
  • e.g., tubing or other hard-to- reach surfaces or for large surface areas, such as kettles and tanks, where the bio burden of the vessel is evaluated.
  • A sterile rinse diluent is added to, or flowed through the area to be sampled and collected for analysis.
  • For large volumes of rinse, a membrane filtration method shall be used to process the sample prior to plating the filter.

Table 9: Neutralizing agents for different classes of sanitizing agents/disinfectants (for reference only)

Non-viable particulates:.

  • Portable particle counters with a short length of sample tubing shall be used for classification purposes because of the relatively higher rate of precipitation of particles ≥5.0 µm in remote sampling systems with long lengths of
  • Isokinetic sample heads shall be used in unidirectional airflow systems.
  • Computerized data collection systems shall be validated per written computerized system procedure.
  • Length of tubing and the number and angle of bends shall be minimized to avoid under recording of particulates.
  • Tubing type and length shall meet vendor specifications to assure maximum recovery of particulates in accordance with ISO 14644-1:2015(E).

Personnel gown and glove monitoring:

  • Sample locations shall at a minimum, include each forearm, chest, forehead, and glove fingertips.
  • Glove monitoring shall be performed for every person at least daily, or in association with each lot. Sampling upon each exit from the area should be considered.
  • Personnel monitoring shall be performed at the conclusion of critical operations and before sanitizing gloves.
  • Retraining shall be performed for operators having OOS monitoring results that exceed a pre-defined frequency.
  • Annual personnel requalification is sufficient for those automated operations where personnel involvement is minimized and monitoring data indicate environmental control.
  • Other gowning sites may be sampled according to an appropriate sampling frequency based on risk to operations, such as for operators involved in repeated or more complex aseptic manipulations; sampling sites shall be justified.

PERIODIC SURVEYS FOR YEASTS AND MOLDS FOR STERILE PRODUCT MANUFACTURING FACILITIES:

  •   Environmental sampling for yeasts and molds shall be performed in all classified areas at all routine sample sites at least semi-annually.
  • These surveys may be performed using Sabouraud’s Dextrose, or equivalent, agar or Soybean Casein Digest Agar with incubation at 20°C-25°C.
  • Yeast and mold data shall be trended to assess effectiveness of the Cleaning and Sanitization Program for controlling yeast and mold populations.
  • Adverse trends may require additional action, such as investigation to identify sources, additional cleaning / sanitization activities and possible modification of the Sanitization.

EM Media Preparation for Sterile product facilities only:

  • Isolates from classified areas, particularly ISO-5/Grade A areas, shall be used in growth promotion and suitability studies, as well as standard ATCC organisms specified in Pharmacopeia for the specific media being challenged.
  • Obligatory microorganisms isolated from the local flora should be used and should be representative of the qualitative trends evaluation made from the identified microorganisms originated from the environment.
  • Storage of environmental isolates should be accomplished through cryopreservation, since there exists no standardized reservoir, e.g. ATCC for these entities.
  • Each identified microbial strain should have unique isolate number that should be allotted as per site procedure after identification of microbial strain.
  • Microbial isolates should be preserved in cryo vials (for bacteria use soybean casein digest medium + 15-20% glycerol and for fungi use sabouraud dextrose broth + 15-20% glycerol) at low temperature (-15 to -70°C) for extended time.
  • The microbial isolate observations  of  colony morphology,  cell characteristics and photograph can be preserved as data base that should be served as a reference for the easy identification of the microbial cell whenever they recur.

**************************************END**************************************

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  • Saudi Pharm J
  • v.25(2); 2017 Feb

Temperature excursion management: A novel approach of quality system in pharmaceutical industry

Quality of pharmaceutical product largely depends upon the environment controls during its storage and handling. Each pharmaceutical product should be handled and stored under specified storage condition labelled on product information data sheet or product pack. Hence the temperature excursions during receipt of raw materials, manufacturing of pharmaceutical products and distribution should be managed during entire product life cycle with holistic approach. The research is based on primary data and exploratory study through literature review. The temperature excursion may be observed during transportation of raw materials manufacturing as well as distribution of pharmaceutical products, which have potential to deteriorate the product quality. Temperature excursion in pharmaceutical industry should be recorded and reported to the manufacturer for further investigation and risk analysis. The concept of temperature excursions, its reasons, consequences and handling mechanism should be well understood to ensure the concerted efforts under the aegis of Quality Management System. Based on the reasons and consequences of temperature excursions during pharmaceutical operations, a system based quality management has been envisaged through this study. The concept and procedure to handle temperature excursion have evolved after this study which shall be useful to pharmaceutical industry as well as to medicine distributors and consumers.

1. Introduction

The pharmaceutical product quality largely depends upon the storage environmental conditions. Natural reasons or human negligence could create uncalled-for situation causing temperature excursions. The most important environmental parameter having significant potential to impact quality of pharmaceutical product is temperature. If the temperature excursions are not handled systematically, there shall be an adverse impact on product quality.

There is a growing need to manage the environment excursions during pharmaceutical operations and its impacts on quality of products. In an era of Quality by Design (QbD) for pharmaceutical products, the attention is paid towards inbuilt quality instead of inspected quantity ( Roy et al., 2012 ). As manufacturers have extensive knowledge about critical product and process parameters and quality attributes, the impact assessment has to be extended to temperature excursions. The temperature and relative humidity (RH) beyond limit shall lead to product degradation rate and microbial growth. This concept is the theoretical basis for the pharmaceutical guidelines that provide recommendations for long-term, intermediate, and accelerated storage conditions and for establishing shelf life periods or expiry dates of products ( Scrivens, 2012 ).

Pharmaceutical regulatory bodies expect strict adherence of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) during plant manufacturing and product distribution processes. GMP and GDP are deemed as synonyms of Quality System in pharmaceutical business. Since temperature excursions are observed during raw material receipt, manufacturing operation and distribution of pharmaceutical products, there is a need of holistic approach of quality system which shall be based on both GMP and GDP.

1.1. Research methodology

The following instruments have been used to generate data for the study:

  • (a) A survey has been conducted amongst pharmaceutical professionals to understand their experience regarding environmental condition during pharmaceutical manufacturing and that during distribution process.
  • (b) The guidance papers issued by drug regulatory agencies and related literature and scientific search engines such as Google were searched for pharmaceutical supply chain risk management studies in English language. Searching through databases was done with different keywords: supply chain risk, Good Distribution Practices, Quality Risk Management, and pharmaceutical. Searching in each database was adapted to databases characteristics and additionally pharmaceutical risk. The result studies and meeting abstracts were screened at 4 steps and exclusion process was based on consensus of both the authors.

1.2. Data and analysis

The research survey study amongst pharmaceutical professionals in India reveals that the records of environment condition (EC) monitoring during manufacturing and distribution operations follow a contrast trend (refer Chart 1 ). The survey alludes that deployment and monitoring of data logger results during manufacturing as per GMP are in place, whereas that during distribution operation is not so methodological.

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Object name is gr5.jpg

Trend of Environment Condition (EC) monitoring practices during manufacturing and distribution operations.

As a part of Quality Management System (QMS), pharmaceutical industry has identified a number of core quality elements which are followed at manufacturing site level. Few of such core elements of plant quality system may be listed as,

  • a. Documents and Record Control: There shall be good documentation practices in organization to ensure the document and online records are adequately maintained.
  • b. Deviation Control: Incidences leading to departure from documented and approved instructions shall be recorded and evaluated for potential impact on product quality.
  • c. Change Control: The changes to an approved design, equipment or system in pharmaceutical facility shall be adequately reviewed and validated.
  • d. Validation Master Plan: The validation master plan shall exhibit management philosophy, strategy and commitment of organization towards validations of processes and qualification of equipment.
  • e. Quality Risk Management: Quality risk to product shall be identified and evaluation shall be made to estimate the severity, occurrence and detectability. A robust quality risk management.
  • f. Training and Awareness: The organization shall develop and implement robust training programme for personnel engaged in GMP operations.
  • g. Market Complaint Handling system: There shall be a documented procedure to receive, log and investigate each market complaint to further facilitate necessary corrective and preventive action.
  • h. Recall Management, etc.: There shall be documented procedure to handle the recall or market returned goods.

It is observed that inadequate QMS components have direct impact on consistency of storage conditions with respect to temperature and humidity. The temperature excursion is a common notion which signified the general environmental excursions (see Fig. 1 ).

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Effect of inadequate Quality System element can cause Environmental Excursions (EC).

A research survey amongst pharmaceutical professionals finds that the core quality assurance aspects are followed by each manufacturing site as a part of cGMP but during distribution practices (out of plant) the above quality elements are not followed meticulously. The environmental excursion management is interlinked with Product Complaint Management, Quality Risk Management, Deviation Management and Change Control Management, sometimes as a cause or else as an effect.

2. Discussions – facets of temperature excursion

Quality and environmental excursions are two important aspects of pharmaceutical operational excellence. An integrated approach for managing the quality system should include the temperature excursion management. The overall temperature excursion management can be laid down in following steps.

2.1. Understanding temperature excursion

The environmental condition during pharmaceutical business is defined by temperature (T) and relative humidity (RH). The temperature and relative humidity are used and monitored during manufacturing processes particularly when the product intermediates are exposed to environment. During packaged conditions temperature is measured, monitored and controlled. Any spike in measured value of T and RH shall be construed as environmental excursion. During manufacturing the temperature is always maintained below 27 °C, and whenever any deviation from this limit is observed, the case is thoroughly investigated and impact on product quality is mitigated.

According to European Compliance Academy, a temperature excursion is the deviation from the labelled storage condition of a product for any duration whether during transportation or distribution. Studies indicate that if there is exposure of product or intermediate beyond specified environmental limits for substantial time, there shall be generation of impurities as result of product degradation. Such degradation products are not only regarded as undesired but also shall have adverse reaction to the patient’s health.

The temperature excursion phenomena are also applicable during manufacturing and transportation of active pharmaceutical ingredients (API) prior to receipt at pharmaceutical manufacturing site. Deviation against storage condition can lead to significant qualitative change in API, such as degradation, decomposition, polymerization and impurity level increase.

2.2. Storage temperature and humidity limits

Specified directions are stated in some monographs with respect to temperature and humidity at which official articles shall be stored and distributed (including the shipment of articles to the customer), when stability data indicate that storage and distribution at a lower or higher temperature and humidity produce undesired results.

Cold chain products are those products which have to be necessarily stored under cold condition (refer Table 1 ). For products from class of cold chain, the storage condition is maintained at 2–8 °C. Similarly the relative humidity shall be maintained below 60% and 40% depending upon the hygroscopic nature of product.

Typical storage conditions.

United States Pharmacopoeia (USP) has described the different labelling terminologies related to temperature conditions. The general chapter of USP clarified various storage labelling conditions.

2.3. Measurement devices

Temperature and Humidity measuring devices (popularly known as data loggers) are available in market, which log the temperature at a defined (preset) interval that can be downloaded in computer system for review, evaluation, investigation and record. Periodic verification of calibration status of temperature data loggers and upgradation of software is the prerequisite of uninterrupted and accurate information about product storage condition.

Calibration and periodic verification of measurement device are keys of correct recording. In addition to that periodic cleaning of measuring device and appropriate precautions should be taken to avoid blockage or damage of sensor. It is recommended to use a temperature measurement reference instrument which is of higher accuracy than the device to be checked. The temperature and relative humidity sensor should be placed on the hottest spot, concluded after temperature mapping of the area.

2.4. Locations where environmental or temperature excursions may take place

To manage the temperature excursion related issue, it is important to know the places where temperature excursion can occur. The deviations can be observed against the temperature limits not only at manufacturing sites or during transportation or distribution rather, it can be caused at the end of business i.e., retail outlets and drug shops (see Fig. 2 ).

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Locations wherein excursions can occur.

2.5. Reason of temperature excursion

In pharmaceutical manufacturing plant and storage area, the specified temperature is maintained with help of air handling units (AHU). The design and capacity of AHU are selected on the basis of volume of work area or manufacturing cubical.

2.5.1. Temperature excursions in manufacturing area caused due to following reasons (not limited to)

  • a. Inadequate number of air handling unit (AHU) installed which are actually required to maintain the desired temperature conditions inside manufacturing shop floor.
  • b. Leakage or rupture from air duct, resulting in insufficient cooling effect.
  • c. Mechanical failure in air handling units (AHU), such as breakdown.
  • d. Power failure making the AHU operation defunct.
  • e. Lack of quality system and weak discipline of Good Manufacturing Practices (GMP) on production shopfloor.
  • f. General awareness about the consequences of not maintaining temperature within limit and undue keenness to prevent power consumption.
  • g. Extreme weather changes and obsolete contingency plan to handle unprecedented temperature fluctuations.

2.5.2. During transportation of pharmaceutical product, following reasons (not limited to) cause temperature excursion

  • a. Unexpected delay in transportation due to which the temperature control cannot be maintained effectively.
  • b. Product pallets are kept in hot zones of airport or shipping yards.
  • c. Reefer containers or refrigerated control vans are not deployed for transportation.
  • d. The transport agency fails to maintain the planned transport condition.
  • e. Higher cost to maintain temperature within limits and other business issues.
  • f. Power failure due to short longevity of power bank during longer travel time.
  • g. Good Distribution Practices (GDP) understanding amongst supply chain personnel about the adverse impact on product quality.

2.6. Consequences of temperature excursion

The storage condition for product is assigned on the basis of scientific studies to avoid deterioration during product life cycle. If the temperature excursion is not taken due care the following negative impacts are commonly noticed :

  • a. Loss of assay.
  • b. Increase of impurity.
  • c. Separation of layers of liquid products.
  • d. Change in dissolution pattern of solid dosage.
  • e. Discolouration of products.

Achieving the stability by design for solid dosage pharmaceutical products shall require establishment of limits for storage temperature (T) and relative humidity (RH). Within these prescribed temperature (T) and relative humidity (RH) limit, the kinetics of degradation of a pharmaceutical product can be estimated using and extended Arrhenius model ( Porter, 2013 ).

An excursion can have a significant impact on quality of products, which can be investigated as a part of therapeutic drug properties. As a consequence of excursion, the following impact can be observed (see Fig. 3 ).

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Impact on quality and therapeutic drug properties due to temperature.

2.7. Review of sensitivity of drug products towards temperature excursions

To control temperature excursions is often complicated because there is no way to predict the condition that the product will be exposed to. The management of temperature excursion becomes more important particularly for the drug products, which are sensitive towards temperature conditions. Due care against potential excursions is mandatory during the course of drug manufacturing as well as during distribution process.

2.7.1. Product sensitive towards higher temperature

Drug product sensitive to higher temperature excursions can depreciate the intended action by receiving the thermal energy. This may instigate,

  • • Transformation of degraded ingredients because of oxidation, hydrolysis, decomposition, polymerization. As longer as the time of exposure of product to unspecified temperature, higher would be the impact on quality.
  • • Modification of the drug dissolution pattern (either higher or lower) in case of solid dosage drug product.
  • • Separation of emulsions.

2.7.2. Product sensitive towards lower temperature

The adverse impact on product quality is not observed only due to exposure to higher temperature. Drug product sensitive to lower temperature can also depreciate the intended action by losing their therapeutic characters. This may cause,

  • • Lattice positions dislocation due to extremely lower temperature.
  • • Change in property of biological products.

2.7.3. Cold chain products

A deficiency in monitoring and maintenance system usually affects the products’ therapeutic properties and causes quality risks such as lack of effect, intoxications. In case of cold chain products the challenge of temperature excursions is bigger, because there is a task to preserve the adequate storage and temperature conditions throughout the product life cycle. Quality Assurance personnel must make sure that conditions of storage are observed at any time during manufacturing, transport and distribution.

2.7.4. In case of lyophilized drug products

Lyophilization process is commonly used for pharmaceuticals/biopharmaceuticals to improve the stability and shelf life. A disruption of the initial freezing rate due to temperature excursion can potentially lead to incomplete crystallization of crystalline excipients or heterogeneous moisture distribution in the lyophilized products. Temperature excursion during drying can lead to collapse or there could be melt back related negative impact on product quality.

3. Result – solution strategy and model for temperature excursion management

3.1. solution strategy against excursions.

In view of significant impact on product quality due to environmental excursions, the pharmaceutical industry should establish a documented programme for ‘Temperature Excursion Management’. As a part of this programme, the storage condition database and standard operating procedure (SOP) are required. The details of strategy are as under.

3.1.1. Development of storage condition database

To handle the environment excursion, the strategic planning, effective packaging and well documented procedure are recommended. Development of storage database of pharmaceutical product is useful to assign the standard storage condition.

The storage conditions suitable for product are assigned through the following information:

  • a. At the product development stage, the semi finished product and final pharmaceutical product dosage are subjected to challenging conditions (i.e., forced conditions) to observe the potential impact on quality attributes.
  • b. Hold time studies are carried out to establish the database for allowable time period at specified storage condition without impacting quality. The quality attributes of product intermediates include chemical, microbiological and pharmacological determinants at various time points of stability.
  • c. Studies of the long term (i.e., real time) and accelerated condition stability study data of each product formula form an assurance for the storage condition that shall be suitable to product safety. The real time stability data are generated in laboratory to assess the change in quality attributes of product throughout the expiration date. The accelerated stability data are generated to evaluate the impact on quality of product under slightly stressed environmental condition.

A freeze/thaw study for multiple cycles should be conducted to specify the effect of freezing, if any, and the subsequent thawing. Samples from different layers (top, middle and bottom) of container are drawn for analysis at the end of the cycle (see Fig. 4 ).

  • a. Know your formula.
  • b. Carryout Quality Risk Analysis.
  • c. Establish Stability Study Protocol.
  • d. Evaluate Stability Study Data.
  • e. Improve Product Formula.
  • f. Redefine Product Formula.

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Temperature Management and Control Cycle.

3.1.2. Thermal packing during transportations

Packaging configuration should include the provision of thermal packing and display of appropriate storage condition. Caution notes to avoid storage outside the specified conditions shall help supply chain personnel to protect the product quality.

The storage condition should be effectively displayed on the packaging of pharmaceutical product. The packaging configuration card must contain the details of data loggers.

3.1.3. Ten step procedure to deal with temperature excursions

The temperature excursion has regulatory implications as well as business impact due to impact on quality.

A standard operating procedure (SOP) compromising of following steps should be established and adherence should be ensured through adequate training to concerned personnel:

  • i. The provision of technical agreement should be laid down in SOP. Technical agreement between manufacturer and distributor should clearly assign the responsibility of notifying the details of environmental excursions during transit, storage and distribution process. A contract is a written agreement between two or more interested parties which creates obligations that are enforceable by law. Before services are provided by a vendor, a contract must be put in place and executed by the parties.
  • – Active Pharmaceutical Ingredient (API) supplier – Pharmaceutical product manufacturer.
  • – Active Pharmaceutical Ingredient (API) supplier – transporter, cargo.
  • – Pharmaceutical product manufacturer – transporter, cargo, etc.
  • ii. Product characteristics database should be accessible to all concerned personnel for ready reference. Such database should clearly mention the storage instruction and precautions prominently highlighted on packs of product. Ideally larger display of storage condition on shipment pack shall alert the distribution agencies to avoid potential excursions.
  • (a) manufacturing facility with special attention on environmental controls,
  • (b) transport media (motor van, shipping containers, air cargo, etc.),
  • (c) replenishment and handling devices,
  • (d) storage warehouse in loaded conditions,
  • (e) distribution centres, and
  • (f) drug seller’s outlet and pharmacy.
  • iv. Standard Operating Procedure (SOP) should be in place for each critical steps of manufacturing and distribution that may have trigger temperature excursions. Adequate training (in the form of personalized, awareness or document read) should be imparted to all operation executives. The key personnel across the pharmaceutical business should be aware about the SOP on investigation, handling and managing the temperature excursions.
  • v. Records related to temperature excursions and duration should be regularly reviewed and approved to ascertain whether an excursion may have occurred and a systematic investigation should be performed. This should be formally signed off physically or electronically.
  • vi. Investigation report against temperature excursions and duration should be notified immediately to the responsible person (as per the technical agreement) or manufacturer in a timely fashion.
  • vii. Product quality risk analysis should be carried out against each case of temperature excursions. As a part of risk evaluation, the specimen complaint sample and control sample (retained by manufacturer) may be simultaneously analysed by using the validated analytical method. Due focus should be there to estimate the loss of assay as well as increase in impurity in sample impacted due to temperature excursion.
  • viii. The stability data should be available with manufacturer against each excursion to evaluate and justify that there is no impact on product quality due to the excursions. The stability study under accelerated condition and freeze–thaw study are the relevant to evaluate the impact on product quality in a scientific manner.
  • An accelerated stability study programme in line with ICH:Q1 guidelines should be carried out.
  • A typical freeze–thaw study comprises of estimating the quality impact due to storage of product at extremely low and high temperatures, such as −20 and +50 °C for a duration up to 12 days in multiple cycles depending upon the proposed route, time and length of travel ( Adadevoh, 2002 , GCC Guidelines, 2007 ).
  • ix. The statistics of temperature excursion cases should be evaluated periodically by quality professionals and in case of recurring observation of excursions are noticed from a particular facility, that particular mode or facility should be subjected to requalification.
  • x. Appropriate corrective actions should be taken to avoid the recurrence of temperature excursions, if any. Modify the storage and transportation conditions on the basis of quality risk management programme.

4. Conclusion

Temperature excursion is a general term that represents the environmental excursions. There is a need of holistic approach to handle the temperature excursions starting from raw material manufacturing site to medicine retailers shop to protect quality of product. The temperature excursion at any stage of pharmaceutical business operation must be reported as soon as possible and investigated appropriately. The consequences of deviation against temperature and humidity limits should be studied appropriately by quality assurance personnel. The risk of temperature excursions cannot be ruled out, but it can be minimized through effective system. Alternative is to use thermal resistant packaging and stringent control measures during transit and shipment, to avert the undesired quality impact on pharmaceutical product. The systematic approach to handle the issues related temperature excursions becomes inevitable for pharmaceutical manufacturers.

Peer review under responsibility of King Saud University.

  • Adadevoh, K., 2002. Short-term, Freeze Thaw and Shipping Studies. ARMWG RFP11 Report.
  • The GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products, 2007, Edition Two (1428 H – 2007G).
  • Porter William R. Degradation of pharmaceutical solids accelerated by changes in both relative humidity and temperature and combined storage temperature and storage relative humidity (T × h) design space for solid products. J. Valid. Technol. 2013; 19 (2) [ Google Scholar ]
  • Roy Souvik, Ruitberg Chiristian, Sethuraman Ananth. Troubleshooting during the manufacturing of lyophilized drug product – being prepared for the unexpected. Am. Pharm. Rev. 2012 [ Google Scholar ]
  • Scrivens G. Mean kinetic relative humidity: A new concept for assessing the impact of variable relative humidity on pharmaceuticals. Pharm. Technol. 2012; 36 (11) [ Google Scholar ]

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Glossary of tourism terms

UN standards for measuring tourism

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Glossary of tourism terms

Tourism is a social, cultural and economic phenomenon which entails the movement of people to countries or places outside their usual environment for personal or business/professional purposes. These people are called visitors (which may be either tourists or excursionists; residents or non-residents) and tourism has to do with their activities, some of which involve tourism expenditure.

A B C D E F G H I J K L M N O P Q R S T U V W Y Z

Activity/activities : In tourism statistics, the term activities represent the actions and behaviors of people in preparation for and during a trip in their capacity as consumers ( IRTS 2008, 1.2 ).

Activity (principal): The principal activity of a producer unit is the activity whose value added exceeds that of any other activity carried out within the same unit ( SNA 2008, 5.8 ).

Activity (productive): The (productive) activity carried out by a statistical unit is the type of production in which it engages. It has to be understood as a process, i.e. the combination of actions that result in a certain set of products. The classification of productive activities is determined by their principal output.

Administrative data : Administrative data is the set of units and data derived from an administrative source. This is a data holding information collected and maintained for the purpose of implementing one or more administrative regulations.

Adventure tourism : Adventure tourism is a type of tourism which usually takes place in destinations with specific geographic features and landscape and tends to be associated with a physical activity, cultural exchange, interaction and engagement with nature. This experience may involve some kind of real or perceived risk and may require significant physical and/or mental effort. Adventure tourism generally includes outdoor activities such as mountaineering, trekking, bungee jumping, rock climbing, rafting, canoeing, kayaking, canyoning, mountain biking, bush walking, scuba diving. Likewise, some indoor adventure tourism activities may also be practiced.

Aggregated data : The result of transforming unit level data into quantitative measures for a set of characteristics of a population.

Aggregation : A process that transforms microdata into aggregate-level information by using an aggregation function such as count, sum average, standard deviation, etc.

Analytical unit : Entity created by statisticians, by splitting or combining observation units with the help of estimations and imputations.

Balance of payments : The balance of payments is a statistical statement that summarizes transactions between residents and non-residents during a period. It consists of the goods and services account, the primary income account, the secondary income account, the capital account, and the financial account ( BPM6, 2.12 ).

Bias : An effect which deprives a statistical result of representativeness by systematically distorting it, as distinct from a random error which may distort on any one occasion but balances out on the average.

Business and professional purpose (of a tourism trip): The business and professional purpose of a tourism trip includes the activities of the self-employed and employees, as long as they do not correspond to an implicit or explicit employer-employee relationship with a resident producer in the country or place visited, those of investors, businessmen, etc. ( IRTS 2008, 3.17.2 ).

Business tourism : Business tourism is a type of tourism activity in which visitors travel for a specific professional and/or business purpose to a place outside their workplace and residence with the aim of attending a meeting, an activity or an event. The key components of business tourism are meetings, incentives, conventions and exhibitions. The term "meetings industry" within the context of business tourism recognizes the industrial nature of such activities. Business tourism can be combined with any other tourism type during the same trip.

Business visitor : A business visitor is a visitor whose main purpose for a tourism trip corresponds to the business and professional category of purpose ( IRTS 2008, 3.17.2 ).

Central Product Classification : The Central Product Classification (CPC) constitutes a complete product classification covering goods and services. It is intended to serve as an international standard for assembling and tabulating all kinds of data requiring product detail, including industrial production, national accounts, service industries, domestic and foreign commodity trade, international trade in services, balance of payments, consumption and price statistics. Other basic aims are to provide a framework for international comparison and promote harmonization of various types of statistics dealing with goods and services.

Census : A census is the complete enumeration of a population or groups at a point in time with respect to well defined characteristics: for example, Population, Production, Traffic on particular roads.

Coastal, maritime and inland water tourism : Coastal tourism refers to land-based tourism activities such as swimming, surfing, sunbathing and other coastal leisure, recreation and sports activities which take place on the shore of a sea, lake or river. Proximity to the coast is also a condition for services and facilities that support coastal tourism. Maritime tourism refers to sea-based activities such as cruising, yachting, boating and nautical sports and includes their respective land-based services and infrastructure. Inland water tourism refers to tourism activities such as cruising, yachting, boating and nautical sports which take place in aquatic- influenced environments located within land boundaries and include lakes, rivers, ponds, streams, groundwater, springs, cave waters and others traditionally grouped as inland wetlands.

Coherence : Adequacy of statistics to be combined in different ways and for various uses.

Competitiveness of a tourism destination : The competitiveness of a tourism destination is the ability of the destination to use its natural, cultural, human, man-made and capital resources efficiently to develop and deliver quality, innovative, ethical and attractive tourism products and services in order to achieve a sustainable growth within its overall vision and strategic goals, increase the added value of the tourism sector, improve and diversify its market components and optimize its attractiveness and benefits both for visitors and the local community in a sustainable perspective.

Consistency : Logical and numerical coherence.

Country of reference : The country of reference refers to the country for which the measurement is done. ( IRTS 2008, 2.15 ).

Country of residence : The country of residence of a household is determined according to the centre of predominant economic interest of its members. If a person resides (or intends to reside) for more than one year in a given country and has there his/her centre of economic interest (for example, where the predominant amount of time is spent), he/she is considered as a resident of this country.

Country-specific tourism characteristic products and activities : To be determined by each country by applying the criteria of IRTS 2008, 5.10 in their own context; for these products, the activities producing them will be considered as tourism characteristic, and the industries in which the principal activity is tourism-characteristic will be called tourism industries ( IRTS 2008, 5.16 ).

Cultural tourism : Cultural tourism is a type of tourism activity in which the visitor's essential motivation is to learn, discover, experience and consume the tangible and intangible cultural attractions/products in a tourism destination. These attractions/products relate to a set of distinctive material, intellectual, spiritual and emotional features of a society that encompasses arts and architecture, historical and cultural heritage, culinary heritage, literature, music, creative industries and the living cultures with their lifestyles, value systems, beliefs and traditions.

Data checking : Activity whereby the correctness conditions of the data are verified. It also includes the specification of the type of error or of the condition not met, and the qualification of the data and their division into "error-free data" and "erroneous data".

Data collection : Systematic process of gathering data for official statistics.

Data compilation : Operations performed on data to derive new information according to a given set of rules.

Data confrontation : The process of comparing data that has generally been derived from different surveys or other sources, especially those of different frequencies, in order to assess and possibly improve their coherency, and identify the reasons for any differences.

Data processing : Data processing is the operation performed on data by the organization, institute, agency, etc., responsible for undertaking the collection, tabulation, manipulation and preparation of data and metadata output.

Data reconciliation : The process of adjusting data derived from two different sources to remove, or at least reduce, the impact of differences identified.

Destination (main destination of a trip): The main destination of a tourism trip is defined as the place visited that is central to the decision to take the trip. See also purpose of a tourism trip ( IRTS 2008, 2.31 ).

Destination management / marketing organization (DMO) : A destination management/marketing organization (DMO) is the leading organizational entity which may encompass the various authorities, stakeholders and professionals and facilitates tourism sector partnerships towards a collective destination vision. The governance structures of DMOs vary from a single public authority to a public/ private partnership model with the key role of initiating, coordinating and managing certain activities such as implementation of tourism policies, strategic planning, product development, promotion and marketing and convention bureau activities. The functions of the DMOs may vary from national to regional and local levels depending on the current and potential needs as well as on the decentralization level of public administration. Not every tourism destination has a DMO.

Documentation: Processes and procedures for imputation,  weighting,  confidentiality  and suppression rules, outlier treatment and data capture should be fully documented by the  survey provider.  Such documentation should be made available to at least  the body financing the survey.

Domestic tourism : Domestic tourism comprises the activities of a resident visitor within the country of reference, either as part of a domestic tourism trip or part of an outbound tourism trip ( IRTS 2008, 2.39 ).

Domestic tourism consumption : Domestic tourism consumption is the tourism consumption of a resident visitor within the economy of reference ( TSA:RMF 2008, figure 2.1 ).

Domestic tourism expenditure : Domestic tourism expenditure is the tourism expenditure of a resident visitor within the economy of reference, (IRTS 2008, 4.15(a)).

Domestic tourism trip : A domestic tourism trip is one with a main destination within the country of residence of the visitor (IRTS 2008, 2.32).

Domestic visitor : As a visitor travels within his/her country of residence, he/she is a domestic visitor and his/her activities are part of domestic tourism.

Durable consumer goods : Durable consumer goods are goods that may be used repeatedly or continuously over a period of a year or more, assuming a normal or average rate of physical usage. When acquired by producers, these are considered to be capital goods used for production processes, as is the case of vehicles, computers, etc. When acquired by households, they are considered to be consumer durable goods ( TSA:RMF 2008, 2.39 ). This definition is identical to the definition of SNA 2008, 9.42 : A consumer durable is a goodthat may be used for purposes of consumption repeatedly or continuously over a period of a year or more.

Dwellings : Each household has a principal dwelling (sometimes also designated as main or primary home), usually defined with reference to time spent there, whose location defines the country of residence and place of usual residence of this household and of all its members. All other dwellings (owned or leased by the household) are considered secondary dwellings ( IRTS 2008, 2.26 ).

Ecotourism : Ecotourism is a type of nature-based tourism activity in which the visitor's essential motivation is to observe, learn, discover, experience and appreciate biological and cultural diversity with a responsible attitude to protect the integrity of the ecosystem and enhance the well-being of the local community. Ecotourism increases awareness towards the conservation of biodiversity, natural environment and cultural assets both among locals and the visitors and requires special management processes to minimize the negative impact on the ecosystem.

Economic analysis : Tourism generates directly and indirectly an increase in economic activity in the places visited (and beyond), mainly due to demand for goods and services thatneed to be produced and provided. In the economic analysis of tourism, one may distinguish between tourism's 'economic contribution' which refers to the direct effect of tourism and is measurable by means of the TSA, and tourism's 'economic impact' which is a much broader concept encapsulating the direct, indirect and induced effects of tourism and which must be estimated by applying models. Economic impact studies aim to quantify economic benefits, that is, the net increase in the wealth of residents resulting from tourism, measured in monetary terms, over and above the levels that would prevail in its absence.

Economic territory : The term "economic territory" is a geographical reference and points to the country for which the measurement is done (country of reference) ( IRTS 2008, 2.15 ).

Economically active population : The economically active population or labour force comprises all persons of either sex who furnish the supply of labour for the production of goods and services as defined by the system of national accounts during a specified time-reference period (ILO, Thirteenth ICLS, 6.18).

Economy (of reference): "Economy" (or "economy of reference") is an economic reference defined in the same way as in the balance of payments and in the system of national accounts: it refers to the economic agents that are resident in the country of reference ( IRTS 2008, 2.15 ).

Education tourism : Education tourism covers those types of tourism which have as a primary motivation the tourist's engagement and experience in learning, self-improvement, intellectual growth and skills development. Education Tourism represents a broad range of products and services related to academic studies, skill enhancement holidays, school trips, sports training, career development courses and language courses, among others.

Employees : Employees are all those workers who hold the type of job defined as "paid employment" (ILO, Fifteenth ICLS, pp. 20-22).

Employer-employee relationship : An employer-employee relationship exists when there is an agreement, which may be formal or informal, between an entity and an individual, normally entered into voluntarily by both parties, whereby the individual works for the entity in return for remuneration in cash or in kind ( BPM6, 11.11 ).

Employers : Employers are those workers who, working on their own account with one or more partners, hold the type of job defined as a "self-employment job" and, in this capacity, on a continuous basis (including the reference period) have engaged one or more persons to work for them in their business as "employee(s)" (ILO, Fifteenth ICLS, pp. 20-22).

Employment : Persons in employment are all persons above a specified age who, during a specified brief period, either one week or one day, were in paid employment or self-employment (OECD GST, p. 170).

Employment in tourism industries : Employment in tourism industries may be measured as a count of the persons employed in tourism industries in any of their jobs, as a count of the persons employed in tourism industries in their main job, or as a count of the jobs in tourism industries ( IRTS 2008, 7.9 ).

Enterprise : An enterprise is an institutional unit engaged in production of goods and/or services. It may be a corporation, a non-profit institution, or an unincorporated enterprise. Corporate enterprises and non-profit institutions are complete institutional units. An unincorporated enterprise, however, refers to an institutional unit —a household or government unit —only in its capacity as a producer of goods and services (OECD BD4, p. 232)

Establishment : An establishment is an enterprise, or part of an enterprise, that is situated in a single location and in which only a single productive activity is carried out or in which the principal productive activity accounts for most of the value added ( SNA 2008, 5.14 ).

Estimation : Estimation is concerned with inference about the numerical value of unknown population values from incomplete data such as a sample. If a single figure is calculated for each unknown parameter the process is called "point estimation". If an interval is calculated within which the parameter is likely, in some sense, to lie, the process is called "interval estimation".

Exports of goods and services : Exports of goods and services consist of sales, barter, or gifts or grants, of goods and services from residents to non-residents (OECD GST, p. 194)

Frame : A list, map or other specification of the units which define a population to be completely enumerated or sampled.

Forms of tourism : There are three basic forms of tourism: domestic tourism, inbound tourism, and outbound tourism. These can be combined in various ways to derive the following additional forms of tourism: internal tourism, national tourism and international tourism.

Gastronomy tourism :  Gastronomy tourism is a type of tourism activity which is characterized by the visitor's experience linked with food and related products and activities while travelling. Along with authentic, traditional, and/or innovative culinary experiences, Gastronomy Tourism may also involve other related activities such as visiting the local producers, participating in food festivals and attending cooking classes. Eno-tourism (wine tourism), as a sub-type of gastronomy tourism, refers to tourism whose purpose is visiting vineyards, wineries, tasting, consuming and/or purchasing wine, often at or near the source.

Goods : Goods are physical, produced objects for which a demand exists, over which ownership rights can be established and whose ownership can be transferred from one institutional unit to another by engaging in transactions on markets ( SNA 2008, p. 623 ).

Gross fixed capital formation : Gross fixed capital formation is defined as the value of institutional units' acquisitions less disposals of fixed assets. Fixed assets are produced assets (such as machinery, equipment, buildings or other structures) that are used repeatedly or continuously in production over several accounting periods (more than one year) ( SNA 2008, 1.52 ).

Gross margin : The gross margin of a provider of reservation services is the difference between the value at which the intermediated service is sold and the value accrued to the provider of reservation services for this intermediated service.

Gross value added : Gross value added is the value of output less the value of intermediate consumption ( TSA:RMF 2008, 3.32 ).

Gross value added of tourism industries : Gross value added of tourism industries (GVATI) is the total gross value added of all establishments belonging to tourism industries, regardless of whether all their output is provided to visitors and the degree of specialization of their production process ( TSA:RMF 2008, 4.86 ).

Grossing up : Activity aimed at transforming, based on statistical methodology, micro-data from samples into aggregate-level information representative of the target population.

Health tourism : Health tourism covers those types of tourism which have as a primary motivation, the contribution to physical, mental and/or spiritual health through medical and wellness-based activities which increase the capacity of individuals to satisfy their own needs and function better as individuals in their environment and society. Health tourism is the umbrella term for the subtypes wellness tourism and medical tourism.

Imputation : Procedure for entering a value for a specific data item where the response is missing or unusable.

Inbound tourism : Inbound tourism comprises the activities of a non-resident visitor within the country of reference on an inbound tourism trip ( IRTS 2008, 2.39 ).

Inbound tourism consumption : Inbound tourism consumption is the tourism consumption of a non-resident visitor within the economy of reference ( TSA:RMF 2008, figure 2.1 ).

Inbound tourism expenditure : Inbound tourism expenditure is the tourism expenditure of a non-resident visitor within the economy of reference ( IRTS 2008, 4.15(b) ).

Innovation in tourism : Innovation in tourism is the introduction of a new or improved component which intends to bring tangible and intangible benefits to tourism stakeholders and the local community, improve the value of the tourism experience and the core competencies of the tourism sector and hence enhance tourism competitiveness and /or sustainability. Innovation in tourism may cover potential areas, such as tourism destinations, tourism products, technology, processes, organizations and business models, skills, architecture, services, tools and/or practices for management, marketing, communication, operation, quality assurance and pricing.

Institutional sector : An aggregation of institutional units on the basis of the type of producer and depending on their principal activity and function, which are considered to be indicative of their economic behaviour.

Institutional unit : The elementary economic decision-making centre characterised by uniformity of behaviour and decision-making autonomy in the exercise of its principal function.

Intermediate consumption : Intermediate consumption consists of the value of the goods and services consumed as inputs by a process of production, excluding fixed assets whose consumption is recorded as consumption of fixed capital ( SNA 2008, 6.213 ).

Internal tourism : Internal tourism comprises domestic tourism and inbound tourism, that is to say, the activities of resident and non-resident visitors within the country of reference as part of domestic or international tourism trips ( IRTS 2008, 2.40(a) ).

Internal tourism consumption : Internal tourism consumption is the tourism consumption of both resident and non-resident visitors within the economy of reference. It is the sum of domestic tourism consumption and inbound tourism consumption ( TSA:RMF 2008, figure 2.1 ).

Internal tourism expenditure : Internal tourism expenditure comprises all tourism expenditure of visitors, both resident and non-resident, within the economy of reference. It is the sum of domestic tourism expenditure and inbound tourism expenditure. It includes acquisition of goods and services imported into the country of reference and sold to visitors. This indicator provides the most comprehensive measurement of tourism expenditure in the economy of reference ( IRTS 2008, 4.20(a) ).

International Standard Industrial Classification of All Economic Activities : The International Standard Industrial Classification of All Economic Activities (ISIC) consists of a coherent and consistent classification structure of economic activities based on a set of internationally agreed concepts, definitions, principles and classification rules. It provides a comprehensive framework within which economic data can be collected and reported in a format that is designed for purposes of economic analysis, decision-taking and policymaking. The classification structure represents a standard format to organize detailed information about the state of an economy according to economic principles and perceptions (ISIC, Rev.4, 1).

International tourism : International tourism comprises inbound tourism and outbound tourism, that is to say, the activities of resident visitors outside the country of reference, either as part of domestic or outbound tourism trips and the activities of non-resident visitors within the country of reference on inbound tourism trips ( IRTS 2008, 2.40(c) ).

International visitor : An international traveller qualifies as an international visitor with respect to the country of reference if: (a) he/she is on a tourism trip and (b) he/she is a non-resident travelling in the country of reference or a resident travelling outside of it ( IRTS 2008, 2.42 ).

Job : The agreement between an employee and the employer defines a job and each self-employed person has a job ( SNA 2008, 19.30 ).

Measurement error : Error in reading, calculating or recording numerical value.

Medical tourism : Medical tourism is a type of tourism activity which involves the use of evidence-based medical healing resources and services (both invasive and non-invasive). This may include diagnosis, treatment, cure, prevention and rehabilitation.

Meetings industry : To highlight purposes relevant to the meetings industry, if a trip's main purpose is business/professional, it can be further subdivided into "attending meetings, conferences or congresses, trade fairs and exhibitions" and "other business and professional purposes". The term meetings industry is preferred by the International Congress and Convention Association (ICCA), Meeting Professionals International (MPI) and Reed Travel over the acronym MICE (Meetings, Incentives, Conferences and Exhibitions) which does not recognize the industrial nature of such activities.

Metadata : Data that defines and describes other data and processes.

MICE : See meetings industry.

Microdata : Non-aggregated observations, or measurements of characteristics of individual units.

Mirror statistics : Mirror statistics are used to conduct bilateral comparisons of two basic measures of a trade flow and are a traditional tool for detecting the causes of asymmetries in statistics (OECD GST, p. 335).

Mountain tourism : Mountain tourism is a type of tourism activity which takes place in a defined and limited geographical space such as hills or mountains with distinctive characteristics and attributes that are inherent to a specific landscape, topography, climate, biodiversity (flora and fauna) and local community. It encompasses a broad range of outdoor leisure and sports activities.

National tourism : National tourism comprises domestic tourism and outbound tourism, that is to say, the activities of resident visitors within and outside the country of reference, either as part of domestic or outbound tourism trips ( IRTS 2008, 2.40(b) ).

National tourism consumption : National tourism consumption is the tourism consumption of resident visitors, within and outside the economy of reference. It is the sum of domestic tourism consumption and outbound tourism consumption ( TSA:RMF 2008, figure 2.1 ).

National tourism expenditure : National tourism expenditure comprises all tourism expenditure of resident visitors within and outside the economy of reference. It is the sum of domestic tourism expenditure and outbound tourism expenditure ( IRTS 2008, 4.20(b) ).

Nationality : The concept of "country of residence" of a traveller is different from that of his/her nationality or citizenship ( IRTS 2008, 2.19 ).

Non-monetary indicators : Data measured in physical or other non-monetary units should not be considered a secondary part of a satellite account. They are essential components, both for the information they provide directly and in order to analyse the monetary data adequately ( SNA 2008, 29.84 ).

Observation unit : entity on which information is received and statistics are compiled.

Outbound tourism : Outbound tourism comprises the activities of a resident visitor outside the country of reference, either as part of an outbound tourism trip or as part of a domestic tourism trip ( IRTS 2008, 2.39(c) ).

Outbound tourism consumption : Outbound tourism consumption is the tourism consumption of a resident visitor outside the economy of reference ( TSA:RMF 2008, figure 2.1 ).

Outbound tourism expenditure : Outbound tourism expenditure is the tourism expenditure of a resident visitor outside the economy of reference ( IRTS 2008, 4.15(c) ).

Output : Output is defined as the goods and services produced by an establishment, a) excluding the value of any goods and services used in an activity for which the establishment does not assume the risk of using the products in production, and b) excluding the value of goods and services consumed by the same establishment except for goods and services used for capital formation (fixed capital or changes in inventories) or own final consumption ( SNA 2008, 6.89 ).

Output (main): The main output of a (productive) activity should be determined by reference to the value added of the goods sold or services rendered (ISIC rev.4, 114).

Pilot survey : The aim of a pilot survey is to test the questionnaire (pertinence of the questions, understanding of questions by those being interviewed, duration of the interview) and to check various potential sources for sampling and non-sampling errors: for instance, the place in which the surveys are carried out and the method used, the identification of any omitted answers and the reason for the omission, problems of communicating in various languages, translation, the mechanics of data collection, the organization of field work, etc.

Place of usual residence : The place of usual residence is the geographical place where the enumerated person usually resides, and is defined by the location of his/her principal dwelling (Principles and recommendations for population and housing censuses of the United Nations, 2.20 to 2.24).

Probability sample : A sample selected by a method based on the theory of probability (random process), that is, by a method involving knowledge of the likelihood of any unit being selected.

Production account : The production account records the activity of producing goods and services as defined within the SNA. Its balancing item, gross value added, is defined as the value of output less the value of intermediate consumption and is a measure of the contribution to GDP made by an individual producer, industry or sector. Gross value added is the source from which the primary incomes of the SNA are generated and is therefore carried forward into the primary distribution of income account. Value added and GDP may also be measured net by deducting consumption of fixed capital, a figure representing the decline in value during the period of the fixed capital used in a production process ( SNA 2008, 1.17 ).

Production : Economic production may be defined as an activity carried out under the control and responsibility of an institutional unit that uses inputs of labour, capital, and goods and services to produce outputs of goods or services ( SNA 2008, 6.24. ).

Purpose of a tourism trip (main): The main purpose of a tourism trip is defined as the purpose in the absence of which the trip would not have taken place ( IRTS 2008, 3.10. ). Classification of tourism trips according to the main purpose refers to nine categories: this typology allows the identification of different subsets of visitors (business visitors, transit visitors, etc.) See also destination of a tourism trip ( IRTS 2008, 3.14 ).

Quality of a tourism destination : Quality of a tourism destination is the result of a process which implies the satisfaction of all tourism product and service needs, requirements and expectations of the consumer at an acceptable price, in conformity with mutually accepted contractual conditions and the implicit underlying factors such as safety and security, hygiene, accessibility, communication, infrastructure and public amenities and services. It also involves aspects of ethics, transparency and respect towards the human, natural and cultural environment. Quality, as one of the key drivers of tourism competitiveness, is also a professional tool for organizational, operational and perception purposes for tourism suppliers.

Questionnaire and Questionnaire design : Questionnaire is a group or sequence of questions designed to elicit information on a subject, or sequence of subjects, from a reporting unit or from another producer of official statistics. Questionnaire design is the design (text, order, and conditions for skipping) of the questions used to obtain the data needed for the survey.

Reference period : The period of time or point in time to which the measured observation is intended to refer.

Relevance : The degree to which statistics meet current and potential users' needs.

Reliability : Closeness of the initial estimated value to the subsequent estimated value.

Reporting unit : Unit that supplies the data for a given survey instance, like a questionnaire or interview. Reporting units may, or may not, be the same as the observation unit.

Residents/non-residents : The residents of a country are individuals whose centre of predominant economic interest is located in its economic territory. For a country, the non-residents are individuals whose centre of predominant economic interest is located outside its economic territory.

Response and non-response : Response and non-response to various elements of a survey entail potential errors.

Response error : Response errors may be defined as those arising from the interviewing process. Such errors may be due to a number of circumstances, such as inadequate concepts or questions; inadequate training; interviewer failures; respondent failures.

Rural tourism : Rural tourism is a type of tourism activity in which the visitor's experience is related to a wide range of products generally linked to nature-based activities, agriculture, rural lifestyle / culture, angling and sightseeing. Rural tourism activities take place in non-urban (rural) areas with the following characteristics:

  • Low population density;
  • Landscape and land-use dominated by agriculture and forestry; and
  • Traditional social structure and lifestyle

Same-day visitor (or excursionist): A visitor (domestic, inbound or outbound) is classified as a tourist (or overnight visitor), if his/her trip includes an overnight stay, or as a same-day visitor (or excursionist) otherwise ( IRTS 2008, 2.13 ).

Sample : A subset of a frame where elements are selected based on a process with a known probability of selection.

Sample survey : A survey which is carried out using a sampling method.

Sampling error : That part of the difference between a population value and an estimate thereof, derived from a random sample, which is due to the fact that only a subset of the population is enumerated.

Satellite accounts : There are two types of satellite accounts, serving two different functions. The first type, sometimes called an internal satellite, takes the full set of accounting rules and conventions of the SNA but focuses on a particular aspect of interest by moving away from the standard classifications and hierarchies. Examples are tourism, coffee production and environmental protection expenditure. The second type, called an external satellite, may add non-economic data or vary some of the accounting conventions or both. It is a particularly suitable way to explore new areas in a research context. An example may be the role of volunteer labour in the economy ( SNA 2008, 29.85 ).

SDMX, Statistical Data and Metadata Exchange : Set of technical standards and content-oriented guidelines, together with an IT architecture and tools, to be used for the efficient exchange and sharing of statistical data and metadata (SDMX).

Seasonal adjustment : Seasonal adjustment is a statistical technique to remove the effects of seasonal calendar influences on a series. Seasonal effects usually reflect the influence of the seasons themselves, either directly or through production series related to them, or social conventions. Other types of calendar variation occur as a result of influences such as number of days in the calendar period, the accounting or recording practices adopted or the incidence of moving holidays.

Self-employment job : Self-employment jobs are those jobs where remuneration is directly dependent upon the profits (or the potential of profits) derived from the goods or services produced.

Self-employed with paid employees : Self-employed with paid employees are classified as employers.

Self-employed without employees : Self-employed without employees are classified as own-account workers.

Services : Services are the result of a production activity that changes the conditions of the consuming units, or facilitates the exchange of products or financial assets. They cannot be traded separately from their production. By the time their production is completed, they must have been provided to the consumers ( SNA 2008, 6.17 ).

Social transfers in kind : A special case of transfers in kind is that of social transfers in kind. These consist of goods and services provided by general government and non-profit institutions serving households (NPISHs) that are delivered to individual households. Health and education services are the prime examples. Rather than provide a specified amount of money to be used to purchase medical and educational services, the services are often provided in kind to make sure that the need for the services is met. (Sometimes the recipient purchases the service and is reimbursed by the insurance or assistance scheme. Such a transaction is still treated as being in kind because the recipient is merely acting as the agent of the insurance scheme) (SNA 2008, 3.83).

Sports tourism : Sports tourism is a type of tourism activity which refers to the travel experience of the tourist who either observes as a spectator or actively participates in a sporting event generally involving commercial and non-commercial activities of a competitive nature.

Standard classification : Classifications that follow prescribed rules and are generally recommended and accepted.

Statistical error : The unknown difference between the retained value and the true value.

Statistical indicator : A data element that represents statistical data for a specified time, place, and other characteristics, and is corrected for at least one dimension (usually size) to allow for meaningful comparisons.

Statistical metadata : Data about statistical data.

Statistical unit : Entity about which information is sought and about which statistics are compiled. Statistical units may be identifiable legal or physical entities or statistical constructs.

Survey : An investigation about the characteristics of a given population by means of collecting data from a sample of that population and estimating their characteristics through the systematic use of statistical methodology.

System of National Accounts : The System of National Accounts (SNA) is the internationally agreed standard set of recommendations on how to compile measures of economic activity in accordance with strict accounting conventions based on economic principles. The recommendations are expressed in terms of a set of concepts, definitions, classifications and accounting rules that comprise the internationally agreed standard for measuring indicators of economic performance. The accounting framework of the SNA allows economic data to be compiled and presented in a format that is designed for purposes of economic analysis, decision-taking and policymaking ( SNA 2008, 1.1 ).

Total tourism internal demand : Total tourism internal demand, is the sum of internal tourism consumption, tourism gross fixed capital formation and tourism collective consumption ( TSA:RMF 2008, 4.114 ). It does not include outbound tourism consumption.

Tourism : Tourism refers to the activity of visitors ( IRTS 2008, 2.9 ).

Tourism characteristic activities : Tourism characteristic activities are the activities that typically produce tourism characteristic products. As the industrial origin of a product (the ISIC industry that produces it) is not a criterion for the aggregation of products within a similar CPC category, there is no strict one-to-one relationship between products and the industries producing them as their principal outputs ( IRTS 2008, 5.11 ).

Tourism characteristic products : Tourism characteristic products are those that satisfy one or both of the following criteria: a) Tourism expenditure on the product should represent a significant share total tourism expenditure (share-of-expenditure/demand condition); b) Tourism expenditure on the product should represent a significant share of the supply of the product in the economy (share-of-supply condition). This criterion implies that the supply of a tourism characteristic product would cease to exist in meaningful quantity in the absence of visitors ( IRTS 2008, 5.10 ).

Tourism connected products : Their significance within tourism analysis for the economy of reference is recognized although their link to tourism is very limited worldwide. Consequently, lists of such products will be country-specific ( IRTS 2008, 5.12 ).

Tourism consumption : Tourism consumption has the same formal definition as tourism expenditure. Nevertheless, the concept of tourism consumption used in the Tourism Satellite Account goes beyond that of tourism expenditure. Besides the amount paid for the acquisition of consumption goods and services, as well as valuables for own use or to give away, for and during tourism trips, which corresponds to monetary transactions (the focus of tourism expenditure), it also includes services associated with vacation accommodation on own account, tourism social transfers in kind and other imputed consumption. These transactions need to be estimated using sources different from information collected directly from the visitors, such as reports on home exchanges, estimations of rents associated with vacation homes, calculations of financial intermediation services indirectly measured (FISIM), etc. ( TSA:RMF 2008, 2.25 ).

Tourism destination : A tourism destination is a physical space with or without administrative and/or analytical boundaries in which a visitor can spend an overnight. It is the cluster (co-location) of products and services, and of activities and experiences along the tourism value chain and a basic unit of analysis of tourism. A destination incorporates various stakeholders and can network to form larger destinations. It is also intangible with its image and identity which may influence its market competitiveness.

Tourism direct gross domestic product : Tourism direct gross domestic product (TDGDP) is the sum of the part of gross value added (at basic prices) generated by all industries in response to internal tourism consumption plus the amount of net taxes on products and imports included within the value of this expenditure at purchasers' prices ( TSA:RMF 2008, 4.96 ).

Tourism direct gross value added : Tourism direct gross value added (TDGVA) is the part of gross value added generated by tourism industries and other industries of the economy that directly serve visitors in response to internal tourism consumption ( TSA:RMF 2008, 4.88 ).

Tourism expenditure : Tourism expenditure refers to the amount paid for the acquisition of consumption goods and services, as well as valuables, for own use or to give away, for and during tourism trips. It includes expenditures by visitors themselves, as well as expenses that are paid for or reimbursed by others ( IRTS 2008, 4.2 ).

Tourism industries : The tourism industries comprise all establishments for which the principal activity is a tourism characteristic activity. Tourism industries (also referred to as tourism activities) are the activities that typically producetourism characteristic products. The term tourism industries is equivalent to tourism characteristic activities and the two terms are sometimes used synonymously in the IRTS 2008, 5.10, 5.11 and figure 5.1 .

Tourism product : A tourism product is a combination of tangible and intangible elements, such as natural, cultural and man-made resources, attractions, facilities, services and activities around a specific center of interest which represents the core of the destination marketing mix and creates an overall visitor experience including emotional aspects for the potential customers. A tourism product is priced and sold through distribution channels and it has a life-cycle.

Tourism ratio : For each variable of supply in the Tourism Satellite Account, the tourism ratiois the ratio between the total value of tourism share and total value of the corresponding variable in the Tourism Satellite Account expressed in percentage form ( TSA:RMF 2008, 4.56 ). (See also Tourism share).

Tourism Satellite Account : The Tourism Satellite Account is the second international standard on tourism statistics (Tourism Satellite Account: Recommended Methodological Framework 2008 –TSA:RMF 2008) that has been developed in order to present economic data relative to tourism within a framework of internal and external consistency with the rest of the statistical system through its link to the System of National Accounts. It is the basic reconciliation framework of tourism statistics. As a statistical tool for the economic accounting of tourism, the TSA can be seen as a set of 10 summary tables, each with their underlying data and representing a different aspect of the economic data relative to tourism: inbound, domestic tourism and outbound tourism expenditure, internal tourism expenditure, production accounts of tourism industries, the Gross Value Added (GVA) and Gross Domestic Product (GDP) attributable to tourism demand, employment, investment, government consumption, and non-monetary indicators.

Tourism Satellite Account aggregates : The compilation of the following aggregates, which represent a set of relevant indicators of the size of tourism in an economy is recommended ( TSA:RMF 2008, 4.81 ):

  • Internal tourism expenditure;
  • Internal tourism consumption;
  • Gross value added of tourism industries (GVATI);
  • Tourism direct gross value added (TDGVA);
  • Tourism direct gross domestic product (TDGDP).

Tourism sector : The tourism sector, as contemplated in the TSA, is the cluster of production units in different industries that provide consumption goods and services demanded by visitors. Such industries are called tourism industries because visitor acquisition represents such a significant share of their supply that, in the absence of visitors, their production of these would cease to exist in meaningful quantity.

Tourism share : Tourism share is the share of the corresponding fraction of internal tourism consumption in each component of supply ( TSA:RMF 2008, 4.51 ). For each industry, the tourism share of output (in value), is the sum of the tourism share corresponding to each product component of its output ( TSA:RMF 2008, 4.55 ). (See also Tourism ratio ).

Tourism single-purpose consumer durable goods : Tourism single-purpose consumer durables is a specific category of consumer durable goods that include durable goods that are used exclusively, or almost exclusively, by individuals while on tourism trips ( TSA:RMF 2008 , 2.41 and Annex 5 ).

Tourism trip : Trips taken by visitors are tourism trips ( IRTS 2008, 2.29 ).

Tourist (or overnight visitor): A visitor (domestic, inbound or outbound) is classified as a tourist (or overnight visitor), if his/her trip includes an overnight stay, or as a same-day visitor (or excursionist) otherwise ( IRTS 2008, 2.13 ).

Tourism value chain : The tourism value chain is the sequence of primary and support activities which are strategically fundamental for the performance of the tourism sector. Linked processes such as policy making and integrated planning, product development and packaging, promotion and marketing, distribution and sales and destination operations and services are the key primary activities of the tourism value chain. Support activities involve transport and infrastructure, human resource development, technology and systems development and other complementary goods and services which may not be related to core tourism businesses but have a high impact on the value of tourism.

Travel / traveller : Travel refers to the activity of travellers. A traveller is someone who moves between different geographic locations, for any purpose and any duration ( IRTS 2008, 2.4 ). The visitor is a particular type of traveller and consequently tourism is a subset of travel.

Travel group : A travel group is made up of individuals or travel parties travelling together: examples are people travelling on the same package tour or youngsters attending a summer camp ( IRTS 2008, 3.5 ).

Travel item (in balance of payments): Travel is an item of the goods and services account of the balance of payments: travel credits cover goods and services for own use or to give away acquired from an economy by non-residents during visits to that economy. Travel debits cover goods and services for own use or to give away acquired from other economies by residents during visits to other economies ( BPM6, 10.86 ).

Travel party : A travel party is defined as visitors travelling together on a trip and whose expenditures are pooled ( IRTS 2008, 3.2 ).

Trip : A trip refers to the travel by a person from the time of departure from his/her usual residence until he/she returns: it thus refers to a round trip. Trips taken by visitors are tourism trips.

Urban/city tourism : Urban/city tourism is a type of tourism activity which takes place in an urban space with its inherent attributes characterized by non-agricultural based economy such as administration, manufacturing, trade and services and by being nodal points of transport. Urban/city destinations offer a broad and heterogeneous range of cultural, architectural, technological, social and natural experiences and products for leisure and business.

Usual environment: The usual environment of an individual, a key concept in tourism, is defined as the geographical area (though not necessarily a contiguous one) within which an individual conducts his/her regular life routines ( IRTS 2008, 2.21 ).

Usual residence : The place of usual residence is the geographical place where the enumerated person usually resides (Principles and recommendations for population and housing censuses of the United Nations, 2.16 to 2.18).

Vacation home : A vacation home (sometimes also designated as a holiday home) is a secondary dwelling that is visited by the members of the household mostly for purposes of recreation, vacation or any other form of leisure ( IRTS 2008, 2.27 ).

Valuables : Valuables are produced goods of considerable value that are not used primarily for purposes of production or consumption but are held as stores of value over time ( SNA 2008, 10.13 ).

Visit : A trip is made up of visits to different places.The term "tourism visit" refers to a stay in a place visited during a tourism trip ( IRTS 2008, 2.7 and 2.33 ).

Visitor : A visitor is a traveller taking a trip to a main destination outside his/her usual environment, for less than a year, for any main purpose (business, leisure or other personal purpose) other than to be employed by a resident entity in the country or place visited ( IRTS 2008, 2.9 ). A visitor (domestic, inbound or outbound) is classified as a tourist (or overnight visitor), if his/her trip includes an overnight stay, or as a same-day visitor (or excursionist) otherwise ( IRTS 2008, 2.13 ).

Wellness tourism : Wellness tourism is a type of tourism activity which aims to improve and balance all of the main domains of human life including physical, mental, emotional, occupational, intellectual and spiritual. The primary motivation for the wellness tourist is to engage in preventive, proactive, lifestyle-enhancing activities such as fitness, healthy eating, relaxation, pampering and healing treatments.

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Definition of excursion noun from the Oxford Advanced Learner's Dictionary

  • on an excursion They've gone on an excursion to York.
  • There are regular weekend excursions throughout the summer.
  • a business trip
  • a five-minute trip by taxi
  • a long and difficult journey across the mountains
  • a tour of Bavaria
  • the first expedition to the South Pole
  • We went on an all-day excursion to the island.
  • The children were on a day’s outing from school.
  • We had a day out at the beach.
  • a(n) foreign/​overseas trip/​journey/​tour/​expedition
  • a bus/​coach/​train/​rail trip/​journey/​tour
  • to go on a(n) trip/​journey/​tour/​expedition/​excursion/​outing/​day out
  • to set out/​off on a(n) trip/​journey/​tour/​expedition/​excursion
  • to make a(n) trip/​journey/​tour/​expedition/​excursion
  • destination
  • Our ship offers 13 different excursions.
  • Princess Tours runs independent excursions from selected hotels.
  • We decided to make an all-day excursion to the island.
  • We signed up for a shore excursion to New Orleans.
  • Optional excursions include a tour of the ancient city and a day's horse-riding.
  • take (somebody on)
  • excursion into
  • excursion to

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Definition of 'excursion'

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Excursion in british english, examples of 'excursion' in a sentence excursion, related word partners excursion, trends of excursion.

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In other languages excursion

  • American English : excursion / ɪkˈskɜrʒən /
  • Brazilian Portuguese : excursão
  • Chinese : 短途旅行
  • European Spanish : excursión
  • French : excursion
  • German : Ausflug
  • Italian : escursione
  • Japanese : 小旅行
  • Korean : 짧은 여행
  • European Portuguese : excursão
  • Spanish : excursión
  • Thai : การเที่ยวพักผ่อนหย่อนใจ, การเที่ยวช่วงสั้นๆ

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  • boat excursion
  • shore excursion
  • fishing excursion
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  1. Year 12 Earth & Environmental Science Excursion

    define environmental excursion

  2. Year 12 Earth & Environmental Science Excursion

    define environmental excursion

  3. Year 12 Earth & Environmental Science Excursion

    define environmental excursion

  4. Year 12 Earth & Environmental Science Excursion

    define environmental excursion

  5. Year 12 Earth & Environmental Science Excursion

    define environmental excursion

  6. Year 12 Earth & Environmental Science Excursion

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  1. environmental

  2. ENVIRONMENT MIN. ON ENVIRONMENTAL ISSUES

  3. Reducing our environmental impact

  4. Environmental

  5. Environmental Issues

  6. Environment issue part 1

COMMENTS

  1. PDF A risk based approach to managing environmental excursions

    Excursion Investigation 1. Sterile manufacturer investigated product contamination. Identification by Vitek MS found product contaminant, settle plate and personnel plate to be Bacillus cohnii. Riboprinter confirmed all three isolates were a genetic strain match and likely from the same source.

  2. PDF Strategies for Managing Environmental Monitoring Investigations

    the following definition: Results of environmental monitoring that may indicate a potential problem with the environmental control sys­ tems in place. It should also be noted that it is a regulatory expecta­ tion that an Adverse Trend be investigated to the same level of scruti­ ny as an Action Level excursion.

  3. Excursion Definition & Meaning

    excursion: [noun] a going out or forth : expedition. a usually brief pleasure trip. a trip at special reduced rates.

  4. PDF Managing Environmental Monitoring Excursions

    CSPs that were prepared during the time of the excursion. More important, if any adverse trends appear, they must be aggressively addressed, as they are indicative of a system that is not properly controlled. This article is the second part of a 2-part feature focusing on the impact of the expected USP <797> revisions on environmental

  5. Performing Investigations for Environmental Excursions

    Environmental excursion investigations are complex and multidisciplinary and require the investigator to illicit information from multiple departments to aid in determining the true root cause. Excursions investigations are aided by a robust environmental trending program that should evaluate data for individual sites, rooms, suites and the ...

  6. Environmental Monitoring (EM)

    Excursion and Recovery Rates of Environmental Monitoring (EM) Results: Excursion and recovery rates are related, but different measures of the microbial quality of the environment. Once alert and action levels are derived, the excursion rate measures the number of samples exceeding the defined alert and action levels.

  7. Handling Temperature Excursions and the Role of Stability Data

    Determine other environmental deleterious conditions; Prepare a Risk Analysis: The customer/patient needs, product type, packaging specifications, and transport conditions should be taken into account. ... Temperature excursion procedure should clearly define the situations that are covered by studies and in which a batch can be released and ...

  8. PDF to Handle Excursions in Environmental Monitoring (EM) and Personnel

    environmental samples are found to contain any level of contamination. For example an incident rate of 1% would mean that only 1% of the samples taken (e.g., 1 of 100 samples) have any contamination regardless of colony number. • This rate should be based on actual monitoring data and should

  9. Temperature excursion management: A novel approach of quality system in

    Temperature excursion is a general term that represents the environmental excursions. There is a need of holistic approach to handle the temperature excursions starting from raw material manufacturing site to medicine retailers shop to protect quality of product.

  10. PDF USP Guidances on Environmental Control including related USP, FDA, EMEA

    Define the appropriate operational controls necessary to ensure an appropriate level of microbial control over non-sterile processes. Give due consideration to location in the overall process , purification steps in the process, route of administration, water activity, etc. Result - a workable approach, but surely not one size fit's all.

  11. Glossary of tourism terms

    Tourism industries (also referred to as tourism activities) are the activities that typically producetourism characteristic products. The term tourism industries is equivalent to tourism characteristic activities and the two terms are sometimes used synonymously in the IRTS 2008, 5.10, 5.11 and figure 5.1.

  12. excursion noun

    excursion a short trip made for pleasure, especially one that has been organized for a group of people: We went on an all-day excursion to the island. outing a short trip made for pleasure or education, usually with a group of people and lasting no more than a day: My project team organized an afternoon outing to celebrate.

  13. EXCURSION

    EXCURSION definition: 1. a short journey usually made for pleasure, often by a group of people: 2. a short involvement…. Learn more.

  14. excursion noun

    Synonyms trip trip journey tour expedition excursion outing day out These are all words for an act of travelling to a place. trip an act of travelling from one place to another, and usually back again:. a business trip; a five-minute trip by taxi; journey an act of travelling from one place to another, especially when they are a long way apart:. a long and difficult journey across the mountains

  15. EXCURSION definition and meaning

    8 meanings: 1. a short outward and return journey, esp for relaxation, sightseeing, etc; outing 2. a group of people going on.... Click for more definitions.

  16. EXCURSION Definition & Usage Examples

    Excursion definition: a short trip or outing to some place, usually for a special purpose and with the intention of a prompt return. See examples of EXCURSION used in a sentence.

  17. Temperature excursion management: A novel approach of quality system in

    An integrated approach for managing the quality system should include the temperature excursion management. The overall temperature excursion management can be laid down in following steps. 2.1. Understanding temperature excursion. The environmental condition during pharmaceutical business is defined by temperature (T) and relative humidity (RH).

  18. excursion

    excursion meaning: a short journey made by a group of people for pleasure: . Learn more.

  19. EXCURSION

    EXCURSION meaning: 1. a short journey usually made for pleasure, often by a group of people: 2. a short involvement…. Learn more.

  20. excursion

    excursion - WordReference English dictionary, questions, discussion and forums. All Free. WordReference.com | ... excursion / ɪkˈskɜːʃən-ʒən / n. a short outward and return journey, esp for relaxation, sightseeing, etc; outing; a group of people going on such a journey

  21. EXCURSION definition in American English

    excursion in American English. (ɪkˈskɜːrʒən, -ʃən) noun. 1. a short trip or outing to some place, usually for a special purpose and with the intention of a prompt return. a pleasure excursion. a scientific excursion. 2. a trip on a train, ship, etc., at a reduced rate.

  22. Environmental Excursion Investigations, Microbial, Labs, RCA

    Dictionary; Search. 0. Your Shopping Cart. Contains 0 items Total: $0.00 View Shopping Cart. Sign In . Log In to ComplianceOnline. Forgot Password. Join for Free; ... Performing Investigations for Environmental Excursions; Webinar not found for Product ID : 701573 +1-888-717-2436 [email protected] ...

  23. EXCURSION

    EXCURSION definition: a short journey made by a group of people for pleasure: . Learn more.