• ASTM E 2500 : 2020

    Current The latest, up-to-date edition.

    Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  10-08-2023

    Publisher:  American Society for Testing and Materials

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    Scope - (Show below) - (Hide below)

    1.1This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: good manufacturing practice (GMP) utility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety.

    1.2For brevity, these are referred to throughout the rest of this guide as manufacturing systems.

    1.3This guide may also be applied to laboratory, information, and medical device manufacturing systems.

    1.4This guide is applicable to both new and existing manufacturing systems. The approach may be used for implementation of changes to existing systems.

    1.5This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.

    1.6This standard does not address employee health and safety, environmental, or other non-GxP regulations. 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.

    1.7This 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.

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

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

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

    ASTM E 2363 : 2023 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
    ASTM E 3106 : 2022 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
    ASTM E 2363 : 2014 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
    ASTM E 3051 : 2016 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing
    ASTM E 2629 : 2020 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
    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 3077 : 2017 : EDT 2 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 2898 : 2020 : REV A Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

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

    ASTM E 2363 : 2023 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
    ASTM E 2537 : 2016 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
    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 2476 : 2022 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
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