• ASTM E 2363 : 2014

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    Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  12-01-2014

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    This terminology covers process analytical technology in the pharmaceutical industry.

    Scope - (Show below) - (Hide below)

    1.1This 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.

    1.2This 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.

    1.3The 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.

    1.4This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.

    1.5An 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.

    1.6The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    General Product Information - (Show below) - (Hide below)

    Committee E 55
    Document Type Reference Material
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM E 1732 : 2019 Standard Terminology Relating to Forensic Science
    ASTM E 2882 : 2012 Standard Guide for Analysis of Clandestine Drug Laboratory Evidence
    ASTM E 2476 : 2016 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
    ASTM E 2537 : 2016 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
    ASTM E 3072 : 2019 Standard Terminology for Industrial Biotechnology
    ASTM E 2500 : 2013 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    ASTM E 3077 : 2017 : EDT 1 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
    ASTM E 2656 : 2016 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
    ASTM E 2968 : 2014 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry
    ASTM E 2891 : 2013 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
    ASTM E 3051 : 2016 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
    ASTM E 2629 : 2019 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM E 2629 : 2011 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
    ASTM E 1287 : 1989 : R1999 Standard Practice for Aseptic Sampling of Biological Materials (Withdrawn 2008)
    ASTM E 2629 : 2019 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
    ASTM E 1285 : 1989 : R1994 Standard Guide for Identification of Bacteriophage Lambda ([lambda]) or Its DNA
    ASTM E 456 : 2002 Standard Terminology for Relating to Quality and Statistics
    ASTM E 1285 : 1989 : R2000 Standard Guide for Identification of Bacteriophage Lambda ([lambda]) or Its DNA
    ASTM E 1564 : 2000 Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
    ASTM E 2500 : 2020 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    ASTM E 456 : 2013 : REV A : R2022 Standard Terminology Relating to Quality and Statistics
    ASTM E 1533 : 1993 Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining
    ASTM E 2500 : 2007 : R2012 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    ASTM E 1286 : 2000 : R2006 Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)
    ASTM E 1344 : 1990 : R2006 Standard Guide for Evaluation of Fuel Ethanol Manufacturing Facilities (Withdrawn 2009)
    ASTM E 1126 : 1994 : REV A Standard Terminology Relating to Biomass Fuels (Withdrawn 2003)
    ASTM E 1532 : 2000 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of the Bisbenzamide DNA-Binding Fluorochrome
    ASTM E 1493 : 2006 Standard Guide for Identification of Bacteriophage M13 or Its DNA (Withdrawn 2014)
    ASTM E 2500 : 2007 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    ASTM E 1531 : 2000 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium
    ASTM E 1536 : 2000 Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by the Large Volume Method
    ASTM E 1285 : 2006 Standard Guide for Identification of Bacteriophage Lambda (λ) or Its DNA (Withdrawn 2014)
    ASTM E 1493 : 2001 Standard Guide for Identification of Bacteriophage M13 or Its DNA
    ASTM E 1565 : 2000 Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
    ASTM E 1566 : 2000 Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
    ASTM E 456 : 2013 : REV A : R2017 : EDT 5 Standard Terminology Relating to Quality and Statistics
    ASTM E 1533 : 2000 Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4'-6-Diamidino-2-2 Phenylindole (DAPI) Staining
    ASTM E 1565 : 2000 : R2019 Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
    ASTM E 1298 : 1989 : R2000 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
    ASTM E 1298 : 1989 : R1994 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products
    ASTM E 1532 : 2000 : R2006 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)
    ASTM E 1286 : 2000 Standard Guide for Identification of Herpes Simplex Virus or its DNA
    ASTM E 1564 : 2000 : R2019 Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
    ASTM E 1566 : 2000 : R2019 Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
    ASTM E 2500 : 2013 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    ASTM E 1564 : 2000 : R2006 Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
    ASTM E 1298 : 2006 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
    ASTM E 1117 : 1997 : R2006 Standard Practice for Design of Fuel-Alcohol Manufacturing Facilities (Withdrawn 2009)
    ASTM E 1565 : 2000 : R2006 Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
    ASTM E 1536 : 2000 : R2006 Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by Large Volume Method (Withdrawn 2014)
    ASTM E 1531 : 2000 : R2006 Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium (Withdrawn 2014)
    ASTM E 1342 : 1997 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 E 1564 : 2000 : R2014 Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
    ASTM E 1565 : 2000 : R2014 Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
    ASTM E 1117 : 1997 Standard Practice for Design of Fuel-Alcohol Manufacturing Facilities
    ASTM E 1493 : 1992 : R1998 Standard Guide for Identification of Bacteriophage M13 or Its DNA
    ASTM E 1285 : 2001 Standard Guide for Identification of Bacteriophage Lambda (λ) or Its DNA
    ASTM E 1566 : 2000 : R2014 Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
    ASTM E 1344 : 1990 : R1997 : EDT 1 Standard Guide for Evaluation of Fuel Ethanol Manufacturing Facilities
    ASTM E 456 : 2013 : REV A : R2017 : EDT 4 Standard Terminology Relating to Quality and Statistics
    ASTM E 456 : 2013 : REV A : R2017 : EDT 6 Standard Terminology Relating to Quality and Statistics
    ASTM E 1533 : 2000 : R2006 Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining (Withdrawn 2014)
    ASTM E 1566 : 2000 : R2006 Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
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