ASTM E2363-04

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.

General Information

• Status: Historical
• Publication Date: 30-Jun-2004
• 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

Relations

• Replaced By: ASTM E2363-04a - Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
• Effective Date: 01-Dec-2004
• Referred By: ASTM E3072-22a - Standard Terminology for Industrial Biotechnology and Synthetic Biology
• Effective Date: 01-Jul-2004
• Referred By: ASTM E2629-20 - Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
• Effective Date: 01-Jul-2004
• Referred By: ASTM E3077-17e2 - Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
• Effective Date: 01-Jul-2004
• Referred By: ASTM E3326-22 - Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
• Effective Date: 01-Jul-2004
• Referred By: ASTM E2810-19 - Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
• Effective Date: 01-Jul-2004
• Referred By: ASTM E2891-20 - Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
• Effective Date: 01-Jul-2004
• Referred By: ASTM E3177-18 - Standard Guide on Sampling for Process Analytical Technology
• Effective Date: 01-Jul-2004
• Referred By: ASTM E2656-16 - Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
• Effective Date: 01-Jul-2004
• Referred By: ASTM E2882-19 - Standard Guide for Analysis of Clandestine Drug Laboratory Evidence
• Effective Date: 01-Jul-2004
• Referred By: ASTM E2968-23 - Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry
• Effective Date: 01-Jul-2004
• Referred By: ASTM E2500-20 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• Effective Date: 01-Jul-2004
• Referred By: ASTM E1732-22 - Standard Terminology Relating to Forensic Science
• Effective Date: 01-Jul-2004
• Referred By: ASTM E2476-22 - Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
• Effective Date: 01-Jul-2004
• Referred By: ASTM E2537-16 - Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
• Effective Date: 01-Jul-2004

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:E2363–04
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.
3
1. Scope Manufacturing and Quality Assurance
FDA/ICH Q7A Guidance Document, GMP Guidance for
1.1 This terminology covers process analytical technology
3
APIs and Its Use During Inspections
in the pharmaceutical industry. Terms are defined as they are
2.2 Other Publication:
used relative to the PAT framework in the pharmaceutical
ISO EN 14971 Medical Devices—Application of Risk
industry. Terms that are generally understood and in common
4
Management for Medical Devices
usage or adequately defined in other readily available refer-
ences are not included except where particular delineation to
3. Terminology
process analytical technology may be more clearly stated.
3.1 Definitions:
1.2 This terminology is therefore intended to be selective of
terms used generally in process analytical technology as it is
acceptance criteria, n—numerical limits, ranges, process
applied in the pharmaceutical industry and published in a
signatures, or other suitable measures that are necessary for
number of documents, such as those listed in the succeeding
making a decision to accept or reject the result of a process,
sections.The listing is also intended to define terms that appear
in-process variable, a product or any other convenient
prominently within other related ASTM standards and do not
subgroups of manufactured units.
appear elsewhere.
batch number, n—a combination of numbers, letters, and/or
1.3 The definitions are substantially identical to those pub-
symbols that uniquely identifies a batch and from which the
lished by the U.S. Food and Drug Administration and other
production and distribution history can be determined.
authoritative bodies, such as ISO, IEC, ITU, and national
computer system, n—a group of hardware components and
standards organizations.
associated software designed and assembled to perform a
1.4 This terminology supplements current documents on
specific function or group of functions.
terminology that concentrate on process analytical technology
FDA/ICH Q7A Guidance
as it is applied in the pharmaceutical industry.
contamination, n—the undesired introduction of impurities of
1.5 An increasing number of product designations and
a chemical or microbiological nature, or of foreign matter,
designations for chemical, physical, mechanical, analytical,
into or onto a raw material, intermediate, API (active
and statistical tests and standards are coming into common
pharmaceutical ingredient), or dosage form during produc-
usage in the literature, regulatory environment, and commerce
tion, sampling, packaging, or repackaging, storage, or trans-
associated with process analytical technology in the pharma-
port. FDA/ICH Q7A Guidance
ceutical industry. Section 2 lists those documents referenced in
contract manufacturer, n—a manufacturer who performs
this terminology.
some aspect of manufacturing on behalf of another entity.
cross-contamination, n—contamination of a material or prod-
2. Referenced Documents
uct with another material or product.
2.1 U.S. Government Publications:
FDA/ICH Q7A Guidance
21 CFR 314.3(b) Applications for FDAApproval to Market
deviation, n—departure from an approved instruction or es-
2
a New Drug—General Provisions—Definitions
tablished standard. FDA/ICH Q7A Guidance
U.S. FDA PAT Guidance Document, Guidance for Industry
drugproduct, n—adrugproductisafinisheddosageform(for
PAT—A Framework for Innovative Pharmaceutical
example, tablets, capsule, or solution) that contains a drug
substance, generally, but not necessarily, in association with
one or more other ingredients. 21 CFR 314.3(b)
1
This terminology is under the jurisdiction of ASTM Committee E55 on
Pharmaceutical Application of Process Analytical Technology and is the direct
3
responsibility of Subcommittee E55.91 on Terminology. Available from Food and Drug Administration, 5600 Fishers Ln., Rockville,
Current edition approved July 1, 2004. Published July 2004. MD 20857.
2 4
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E2363–04
impurity, n—any comp
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