ASTM E2363-06a
(Terminology)Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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 references 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 lists those documents referenced in this terminology.
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Designation: E2363 − 06a
StandardTerminology Relating to
Process Analytical Technology in the Pharmaceutical
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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
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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 2.2 U.S. Government Publications:
21 CFR 210.3(b) Current Good Manufacturing Practice in
industry. Terms that are generally understood and in common
usage or adequately defined in other readily available refer- Manufacturing,Processing,Packing,orHoldingofDrugs;
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General—Definitions
ences are not included except where particular delineation to
process analytical technology may be more clearly stated. 21 CFR 314.3(b) Applications for FDAApproval to Market
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a New Drug—General Provisions—Definitions
1.2 This terminology is therefore intended to be selective of
FDA/ICH Q7A Guidance Document GMP Guidance for
terms used generally in process analytical technology as it is
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APIs and Its Use During Inspections
applied in the pharmaceutical industry and published in a
FDA/ICH Q9 Guidance for Industry—Quality Risk Man-
number of documents, such as those listed in the succeeding
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agement
sections.The listing is also intended to define terms that appear
U.S. FDA PAT Guidance Document Guidance for Industry
prominently within other related ASTM standards and do not
PAT—A Framework for Innovative Pharmaceutical
appear elsewhere.
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Manufacturing and Quality Assurance
1.3 The definitions are substantially identical to those pub-
2.3 Other Publication:
lished by the U.S. Food and Drug Administration and other
ISO EN 14971 Medical Devices—Application of Risk Man-
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authoritative bodies, such as ISO, IEC, ITU, and national
agement for Medical Devices
standards organizations.
3. Terminology
1.4 This terminology supplements current documents on
3.1 Definitions:
terminology that concentrate on process analytical technology
acceptance criteria, n—numerical limits, ranges, process
as it is applied in the pharmaceutical industry.
signatures, or other suitable measures that are necessary for
1.5 An increasing number of product designations and
making a decision to accept or reject the result of a process,
designations for chemical, physical, mechanical, analytical,
in-process variable, a product or any other convenient
and statistical tests and standards are coming into common
subgroups of manufactured units.
usage in the literature, regulatory environment, and commerce
associated with process analytical technology in the pharma-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ceutical industry. Section 2 lists those documents referenced in
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
this terminology.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
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AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
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This terminology is under the jurisdiction of ASTM Committee E55 on 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
Manufacture of Pharmaceutical Products and is the direct responsibility of Subcom- www.access.gpo.gov.
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mittee E55.91 on Terminology. Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
Current edition approved July 15, 2006. Published July 2006. Originally Rockville, MD 20857, http://www.fda.gov.
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approved in 2004. Last previous edition approved in 2006 as E2363 – 06. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/E2363-06A. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E2363 − 06a
analyzer, n—an instrument designed to measure and report a in-line measurements, n—measurement where the sample is
property of the process, material, or environmental condi- not removed from the process stream, and can be invasive or
tion. non-invasive.
at-line measurements, n—measurement where the sample is
in-process material, n—any material(s) fabricated,
removed, isolated from, and analyzed in close proximity to compounded, blended, or synthesized using a chemical,
the process stream.
physical, or biological process that is produced for and being
usedin
...
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