ASTM E2363-05a
(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 2 lists those documents referenced in this terminology.
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Designation:E2363–05a
Standard Terminology Relating to
Process Analytical Technology in the Pharmaceutical
1
Industry
This standard is issued under the fixed designation E 2363; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope PAT—A Framework for Innovative Pharmaceutical
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Manufacturing and Quality Assurance
1.1 This terminology covers process analytical technology
FDA/ICH Q7A Guidance Document, GMP Guidance for
in the pharmaceutical industry. Terms are defined as they are
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APIs and Its Use During Inspections
used relative to the PAT framework in the pharmaceutical
2.2 Other Publication:
industry. Terms that are generally understood and in common
ISO EN 14971 Medical Devices—Application of Risk
usage or adequately defined in other readily available refer-
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Management for Medical Devices
ences are not included except where particular delineation to
process analytical technology may be more clearly stated.
3. Terminology
1.2 This terminology is therefore intended to be selective of
3.1 Definitions:
terms used generally in process analytical technology as it is
applied in the pharmaceutical industry and published in a
acceptance criteria, n—numerical limits, ranges, process
number of documents, such as those listed in the succeeding
signatures, or other suitable measures that are necessary for
sections.The listing is also intended to define terms that appear
making a decision to accept or reject the result of a process,
prominently within other related ASTM standards and do not
in-process variable, a product or any other convenient
appear elsewhere.
subgroups of manufactured units.
1.3 The definitions are substantially identical to those pub-
analyzer, n—an instrument designed to measure a property of
lished by the U.S. Food and Drug Administration and other
the process, material, or environmental condition.
authoritative bodies, such as ISO, IEC, ITU, and national
at-line measurements, n—measurement where the sample is
standards organizations.
removed, isolated from, and analyzed in close proximity to
1.4 This terminology supplements current documents on
the process stream.
terminology that concentrate on process analytical technology
batch number, n—a combination of numbers, letters, and/or
as it is applied in the pharmaceutical industry.
symbols that uniquely identifies a batch and from which the
1.5 An increasing number of product designations and
production and distribution history can be determined.
designations for chemical, physical, mechanical, analytical,
computer system, n—a group of hardware components and
and statistical tests and standards are coming into common
associated software designed and assembled to perform a
usage in the literature, regulatory environment, and commerce
specific function or group of functions.
associated with process analytical technology in the pharma-
FDA/ICH Q7A Guidance
ceutical industry. Section 2 lists those documents referenced in
contamination, n—the undesired introduction of impurities of
this terminology.
a chemical or microbiological nature, or of foreign matter,
into or onto a raw material, intermediate, API (active
2. Referenced Documents
pharmaceutical ingredient), or dosage form during produc-
2.1 U.S. Government Publications:
tion, sampling, packaging, or repackaging, storage, or trans-
21 CFR 314.3(b) Applications for FDAApproval to Market
port. FDA/ICH Q7A Guidance
2
a New Drug—General Provisions—Definitions
contract manufacturer, n—a manufacturer who performs
U.S. FDA PAT Guidance Document, Guidance for Industry
some aspect of manufacturing on behalf of another entity.
cross-contamination, n—contamination of a material or prod-
uct with another material or product.
FDA/ICH Q7A Guidance
1
This terminology is under the jurisdiction of ASTM Committee E55 on
Pharmaceutical Application of Process Analytical Technology and is the direct
responsibility of Subcommittee E55.91 on Terminology.
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Current edition approved Aug. 15, 2005. Published September 2005. Originally Available from Food and Drug Administration, 5600 Fishers Ln., Rockville,
approved in 2004. Last previous edition approved in 2005 as E 2363 – 05. MD 20857.
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E2363–05a
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