ASTM E2363-23
(Terminology)Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
SCOPE
1.1 This standard covers terminology used by the E55 Committee relating to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to pharmaceutical and biopharmaceutical manufacturing may be more clearly stated.
1.2 This terminology is, therefore, intended to be selective of terms used generally in the manufacture of pharmaceutical and biopharmaceutical products and published in a number of documents such as those listed in the succeeding section. The listing is also intended to define terms that appear prominently within other related ASTM International standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by regulatory agencies such as the U.S. Food and Drug Administration, European Medicines Agency, Pharmaceutical and Medical Devices Agency (Japan), other and national competent authorities (human) as well as other authoritative bodies, such as ICH, ISO, and national standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on the manufacture of pharmaceutical and biopharmaceutical products.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with the manufacture of pharmaceutical and biopharmaceutical products.
1.6 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2363 − 23
Standard Terminology Relating to
Manufacturing of Pharmaceutical and Biopharmaceutical
Products in the Pharmaceutical and Biopharmaceutical
1
Industry
This standard is issued under the fixed designation E2363; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This standard covers terminology used by the E55
responsibility of the user of this standard to establish appro-
Committee relating to pharmaceutical and biopharmaceutical
priate safety, health, and environmental practices and deter-
industry for manufacture of pharmaceutical and biopharmaceu-
mine the applicability of regulatory limitations prior to use.
tical products. Terms that are generally understood and in
1.8 This international standard was developed in accor-
common usage or adequately defined in other readily available
dance with internationally recognized principles on standard-
references are not included except where particular delineation
ization established in the Decision on Principles for the
to pharmaceutical and biopharmaceutical manufacturing may
Development of International Standards, Guides and Recom-
be more clearly stated.
mendations issued by the World Trade Organization Technical
1.2 This terminology is, therefore, intended to be selective
Barriers to Trade (TBT) Committee.
of terms used generally in the manufacture of pharmaceutical
and biopharmaceutical products and published in a number of
2. Referenced Documents
documents such as those listed in the succeeding section. The
2
listing is also intended to define terms that appear prominently 2.1 ASTM Standards:
within other related ASTM International standards and do not E456 Terminology Relating to Quality and Statistics
appear elsewhere. E869 Test Method for Performance Evaluation of Fuel
Ethanol Manufacturing Facilities
1.3 The definitions are substantially identical to those pub-
E1117 Practice for Design of Fuel-Alcohol Manufacturing
lished by regulatory agencies such as the U.S. Food and Drug
Facilities
Administration, European Medicines Agency, Pharmaceutical
E1126 Terminology Relating to Biomass Fuels (Withdrawn
and Medical Devices Agency (Japan), other and national
3
2003)
competent authorities (human) as well as other authoritative
E1285 Guide for Identification of Bacteriophage Lambda (λ)
bodies, such as ICH, ISO, and national standards organizations.
3
or Its DNA (Withdrawn 2014)
1.4 This terminology supplements current documents on
E1286 Guide for Identification of Herpes Simplex Virus or
terminology that concentrate on the manufacture of pharma-
3
Its DNA (Withdrawn 2014)
ceutical and biopharmaceutical products.
E1287 Practice for Aseptic Sampling of Biological Materials
3
1.5 An increasing number of product designations and
(Withdrawn 2008)
designations for chemical, physical, mechanical, analytical,
E1298 Guide for Determination of Purity, Impurities, and
and statistical tests and standards are coming into common
Contaminants in Biological Drug Products (Withdrawn
3
usage in the literature, regulatory environment, and commerce
2014)
associated with the manufacture of pharmaceutical and bio-
E1342 Practice for Preservation by Freezing, Freeze-Drying,
pharmaceutical products.
and Low Temperature Maintenance of Bacteria, Fungi,
Protista, Viruses, Genetic Elements, and Animal and Plant
1.6 Units—The values stated in SI units are to be regarded
3
Tissues (Withdrawn 2011)
as the standard. No other units of measurement are included in
this standard.
1 2
This terminology is under the jurisdiction of ASTM Committee E55 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
responsibility of Subcommittee E55.91 on Terminology. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Jan. 1, 2023. Published February 2023. Originally the ASTM website.
3
approved in 2004. Last previous edition approved in 2014 as E2363 – 14. DOI: The last approved version of this historical standard is referenced on www.ast-
10.1520/E2363-23. m.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2363 − 14 E2363 − 23
Standard Terminology Relating to
Process Analytical Technology Manufacturing of
Pharmaceutical and Biopharmaceutical Products in the
1
Pharmaceutical and Biopharmaceutical Industry
This standard is issued under the fixed designation E2363; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used
relative to the PAT framework in the pharmaceutical industry. standard covers terminology used by the E55 Committee relating
to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. Terms that
are generally understood and in common usage or adequately defined in other readily available eferencesreferences are not
included except where particular delineation to process analytical technology pharmaceutical and biopharmaceutical manufactur-
ing may be more clearly stated.
1.2 This terminology is thereforeis, therefore, intended to be selective of terms used generally in process analytical technology as
it is applied in the pharmaceutical industry the manufacture of pharmaceutical and biopharmaceutical products and published in
a number of documents,documents such as those listed in the succeeding sections.section. The listing is also intended to define
terms that appear prominently within other related ASTM International standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by regulatory agencies such as the U.S. Food and Drug
Administration and other Administration, European Medicines Agency, Pharmaceutical and Medical Devices Agency (Japan),
other and national competent authorities (human) as well as other authoritative bodies, such as ICH, ISO, IEC, ITU, and national
standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is
applied in the pharmaceutical industry.the manufacture of pharmaceutical and biopharmaceutical products.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical
tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process
analytical technology in the pharmaceutical industry. Sectionthe manufacture of pharmaceutical and biopharmaceutical 2 lists those
documents referenced in this terminology.products.
1.6 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this
standard.
1
This terminology is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility
of Subcommittee E55.91 on Terminology.
Current edition approved Dec. 1, 2014Jan. 1, 2023. Published January 2015February 2023. Originally approved in 2004. Last previous edition approved in 20062014 as
E2363 – 06a.E2363 – 14. DOI: 10.1520/E2363-14.10.1520/E2363-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E2363 − 23
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
E456 Terminology Relating to Quality and Statistics
E869 Test Method for Performance Evaluation of Fuel Ethanol Manufacturing Facilities
E1117 Practice for Design of Fuel-Alcohol Manufacturing Facilities
3
E1126 Terminology Relating to Biomass Fuels (Withdrawn 2003)
3
E1285 Guide for Identification of Bacteriophage Lambda (λ) or It
...
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