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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 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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
U.S. Government Publications21 CFR 210.3(b) Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General--Definitions 21 CFR 314.3(b) Applications for FDA Approval to Market a New Drug--General Provisions--Definitions
ICH PublicationsICHQ10 Guidance for Industry--Pharmaceutical Quality System ICHQ11 Guidance for Industry--Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) ICHQ6A Guidance for Industry--Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances ICHQ6B Guidance for Industry--Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products ICHQ7 Guidance for Industry--Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients ICHQ8(R2) Guidance for Industry--Pharmaceutical Development ICHQ9 Guidance for Industry--Quality Risk Management ICHR2(Q1) Validation of Analytical Procedures: Text and Methodology
ISO PublicationsISO 9000:2005 Quality Management Systems--Fundamentals and Vocabulary ISO EN 14971:201 Medical Devices--Application of Risk Management for Medical Devices ISOGuide73:2009 Risk Management--Vocabulary ISO/IECGuide51:2014 Safety Aspects--Guidelines for Their Inclusion in Standards
ICS Number Code 01.040.11 (Health care technology (Vocabularies)); 11.120.01 (Pharmaceutics in general)
UNSPSC Code 85121902(Commercial pharmaceutical services)
ASTM E2363-14, Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry, ASTM International, West Conshohocken, PA, 2014, www.astm.orgBack to Top