ASTM E2363-14

Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

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. Terms that are generally understood and in common usage or adequately defined in other readily available eferences are not included except where particular delineation to process analytical technology may be more clearly stated.  
1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.  
1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as 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.  
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. Section 2 lists those documents referenced in this terminology.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

General Information

• Status: Historical
• Publication Date: 30-Nov-2014
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.120.01 - Pharmaceutics in general
• Technical Committee: E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
• Drafting Committee: E55.91 - Terminology

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2363 − 14
Standard Terminology Relating to
Process Analytical Technology in the Pharmaceutical
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 2. Referenced Documents
2
1.1 This terminology covers process analytical technology
2.1 ASTM Standards:
in the pharmaceutical industry. Terms are defined as they are
E456 Terminology Relating to Quality and Statistics
used relative to the PAT framework in the pharmaceutical
E869 Test Method for Performance Evaluation of Fuel
industry. Terms that are generally understood and in common
Ethanol Manufacturing Facilities
usage or adequately defined in other readily available eferences
E1117 Practice for Design of Fuel-Alcohol Manufacturing
are not included except where particular delineation to process Facilities
analytical technology may be more clearly stated.
E1126 Terminology Relating to Biomass Fuels (Withdrawn
3
2003)
1.2 This terminology is therefore intended to be selective of
E1285 Guide for Identification of Bacteriophage Lambda (λ)
terms used generally in process analytical technology as it is
3
or Its DNA (Withdrawn 2014)
applied in the pharmaceutical industry and published in a
E1286 Guide for Identification of Herpes Simplex Virus or
number of documents, such as those listed in the succeeding
3
Its DNA (Withdrawn 2014)
sections. The listing is also intended to define terms that appear
E1287 Practice for Aseptic Sampling of Biological Materials
prominently within other related ASTM standards and do not
3
(Withdrawn 2008)
appear elsewhere.
E1298 Guide for Determination of Purity, Impurities, and
Contaminants in Biological Drug Products (Withdrawn
1.3 The definitions are substantially identical to those pub-
3
2014)
lished by the U.S. Food and Drug Administration and other
E1342 Practice for Preservation by Freezing, Freeze-Drying,
authoritative bodies, such as ISO, IEC, ITU, and national
and Low Temperature Maintenance of Bacteria, Fungi,
standards organizations.
Protista, Viruses, Genetic Elements, and Animal and Plant
3
1.4 This terminology supplements current documents on
Tissues (Withdrawn 2011)
terminology that concentrate on process analytical technology
E1344 Guide for Evaluation of Fuel Ethanol Manufacturing
as it is applied in the pharmaceutical industry.
Facilities
E1493 Guide for Identification of Bacteriophage M13 or Its
1.5 An increasing number of product designations and
3
DNA (Withdrawn 2014)
designations for chemical, physical, mechanical, analytical,
E1531 Practice for Detection of Mycoplasma Contamination
and statistical tests and standards are coming into common
of Cell Cultures by Growth on Agarose Medium (With-
usage in the literature, regulatory environment, and commerce
3
drawn 2014)
associated with process analytical technology in the pharma-
E1532 Practice for Detection of Mycoplasma Contamination
ceutical industry. Section 2 lists those documents referenced in
of Cell Cultures by Use of Bisbenzamide DNA-Binding
this terminology.
3
Fluorochrome (Withdrawn 2014)
1.6 The values stated in SI units are to be regarded as E1533 Practice for Indirect Detection of Mycoplasma in Cell
standard. No other units of measurement are included in this
Culture by 4'-6-Diamidino-2-2 Phenylindole (DAPI)
3
standard. Staining (Withdrawn 2014)
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 [e-mail]. 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 Dec. 1, 2014. Published January 2015. Originally the ASTM website.
3
approved in 2004. Last previous edition approved in 2006 as E2363 – 06a. DOI: The last approved version of this historical standard is referenced on www.ast-
10.1520/E2363-14. m.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2363 − 14
E1536 Practice for Detection of Mycoplasma Contamination 3. Terminology
of Bovine Serum by Large Volume Method (Withdrawn
3.1 Definitions:
3
2014)
acceptance criteria, n—numerical limits, ranges, or other
E1564 Guide for Design and Maintenance of Low-
suitable measures for acceptance of test results. ICH Q7
Temperature Storage Facilities fo
...

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 − 06a E2363 − 14
Standard Terminology Relating to
Process Analytical Technology in the Pharmaceutical
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
1.1 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. Terms that are generally understood and in common usage or
adequately defined in other readily available referenceseferences are not included except where particular delineation to process
analytical technology may be more clearly stated.
1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied
in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing
is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other
authoritative bodies, such as 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.
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. Section 2 lists those documents referenced in this terminology.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 Its DNA (Withdrawn 2014)
3
E1286 Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)
3
E1287 Practice for Aseptic Sampling of Biological Materials (Withdrawn 2008)
3
E1298 Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
E1342 Practice for Preservation by Freezing, Freeze-Drying, and Low Temperature Maintenance of Bacteria, Fungi, Protista,
3
Viruses, Genetic Elements, and Animal and Plant Tissues (Withdrawn 2011)
E1344 Guide for Evaluation of Fuel Ethanol Manufacturing Facilities
3
E1493 Guide for Identification of Bacteriophage M13 or Its DNA (Withdrawn 2014)
E1531 Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium (Withdrawn
3
2014)
1
This terminology is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.91
on Terminology.
Current edition approved July 15, 2006Dec. 1, 2014. Published July 2006January 2015. Originally approved in 2004. Last previous edition approved in 2006 as
E2363 – 06.E2363 – 06a. DOI: 10.1520/E2363-06A.10.1520/E2363-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2363 − 14
E1532 Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding
3
Fluorochrome (Withdrawn 2014)
E1533 Practice for Indirect Detection of Mycoplasma in Cell Culture by 4'-6-Diamidino-2-2 Phenylindole (DAPI) Staining
3
(Withdrawn 2014)
3
E1536 Practice for Detecti
...