ASTM E2363-23
Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry

Standard No.

ASTM E2363-23

Release Date

2023

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM E2363-23

Scope

1.1 This standard covers terminology used by the E55 Committee relating to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. 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 pharmaceutical and biopharmaceutical manufacturing may be more clearly stated. 1.2 This terminology is, therefore, intended to be selective of terms used generally in the manufacture of pharmaceutical and biopharmaceutical products and published in a number of documents such as those listed in the succeeding section. The listing is also intended to define terms that appear prominently within other related ASTM International standards and do not appear elsewhere. 1.3 The definitions are substantially identical to those published by regulatory agencies such as the U.S. Food and Drug Administration, European Medicines Agency, Pharmaceutical and Medical Devices Agency (Japan), other and national competent authorities (human) as well as other authoritative bodies, such as ICH, ISO, and national standards organizations. 1.4 This terminology supplements current documents on terminology that concentrate on the manufacture of pharmaceutical and biopharmaceutical products. 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 the manufacture of pharmaceutical and biopharmaceutical products. 1.6 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM E2363-23 Referenced Document

• ASTM E1117 Standard Practice for Design of Fuel-Alcohol Manufacturing Facilities
• ASTM E1126 Standard Terminology Relating to Biomass Fuels (Withdrawn 2003)
• ASTM E1285 Standard Guide for Identification of Bacteriophage Lambda ([lambda]) or Its DNA
• ASTM E1286 Standard Guide for Identification of Herpes Simplex Virus or Its DNA *， 2024-04-22 Update
• ASTM E1287 Standard Practice for Aseptic Sampling of Biological Materials
• ASTM E1298 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
• ASTM E1342 Standard Practice for Preservation by Freezing, Freeze-Drying, and Low Temperature Maintenance of Bacteria, Fungi, Protista, Viruses, Genetic Elements, and Animal and Plant Tissues
• ASTM E1344 Standard Guide for Evaluation of Fuel Ethanol Manufacturing Facilities
• ASTM E1493 Standard Guide for Identification of Bacteriophage M13 or Its DNA
• ASTM E1531 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium *， 2024-04-22 Update
• ASTM E1532 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome *， 2024-04-22 Update
• ASTM E1533 Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining
• ASTM E1536 Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by Large Volume Method *， 2024-04-22 Update
• ASTM E1564 Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
• ASTM E1565 Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
• ASTM E1566 Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
• ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• ASTM E2629 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
• ASTM E456 Standard Terminology for Relating to Quality and Statistics
• ASTM E869 Standard Test Method for Performance Evaluation of Fuel Ethanol Manufacturing Facilities

ASTM E2363-23 history

• 2023 ASTM E2363-23 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
• 2014 ASTM E2363-14 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
• 2006 ASTM E2363-06a Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
• 2006 ASTM E2363-06 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
• 2005 ASTM E2363-05b Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
• 2005 ASTM E2363-05a Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
• 2005 ASTM E2363-05 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
• 2004 ASTM E2363-04a Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
• 2004 ASTM E2363-04 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry