ASTM E2500 - 13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment


    Citing ASTM Standards Citation data is made available by participants in CrossRefs Cited-by Linking service. A comprehensive list of citations to this standard are listed here.

    E2476 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

    E2629 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

    E2656 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

    E2898 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications


    Referenced ASTM Standards The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

    E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

    E2475 Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

    E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

    E2537 Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing

    E2629 Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems