ASTM E2363-14
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
- Standard No.
- ASTM E2363-14
- Release Date
- 2014
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM E2363-23
- Latest
- ASTM E2363-23
- 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 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 2 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.
ASTM E2363-14 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- ASTM E1126 Standard Terminology Relating to Biomass Fuels (Withdrawn 2003)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
- 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
- ASTM E1532 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome
- 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
- 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 E2363-14 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
