Pharmaceutical Application Standards

    ASTM's pharmaceutical application standards cover process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry. These pharmaceutical application standards are valuable to manufacturers of pharmaceuticals and pharmaceutical equipment, federal agencies, design professionals, professional societies, trade associations, financial organizations, and academia.

    List of pharmaceutical application standards developed by ASTM:


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    General Biopharmaceutical Standards

    DesignationTitle
    E1564 - 00(2006) Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
    E1565 - 00(2006) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
    E1566 - 00(2006) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
    E2097 - 00(2006) Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products
    E2888 - 12 Standard Practice for Process for Inactivation of Rodent Retrovirus by pH

    General Pharmaceutical Standards

    DesignationTitle
    E2500 - 13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    E2503 - 13 Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
    E2537 - 08 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing
    E2656 - 10 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
    E2810 - 11e2 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
    F838 - 05(2013) Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

    Process Understanding and PAT System Management, Implementation and Practice

    DesignationTitle
    E2474 - 14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
    E2475 - 10 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
    E2476 - 09 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
    E2629 - 11 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
    E2891 - 13 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
    E2898 - 14 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

    Terminology

    DesignationTitle
    E2363 - 06a Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

    Other standards developed by ASTM committees:


    3D Imaging Standards

    Additive Manufacturing Standards

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    Aerospace Material Standards

    Analytical Chemistry Standards

    Asset Management Standards

    Atmospheric Analysis Standards

    Biotechnology Standards

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    Coal Standards and Gas Standards

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    Corrosion Standards and Wear Standards

    Durability of Nonmetallic Material Standards

    Electrical Insulating Material Standards

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    Medical Device Standards and Implant Standards