Subcommittee E55.03 on General Pharmaceutical Standards

    Showing results 1-12 of 12 matching ACTIVE standards under the jurisdiction of E55.03     E55 Home

    E2500-20 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

    E2503-13(2020) Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

    E2537-16 Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing

    E2656-16 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

    E2810-19 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

    E3051-16 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing

    E3060-16 Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy

    E3077-17e2 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

    E3106-18e1 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

        See also WK73120 proposed revision

    E3219-20 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)

    E3263-20 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

    F838-20 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

    Showing results 1-5 of 5 matching Proposed New Standards under the jurisdiction of E55.03     E55 Home

    WK52609 Validating End-User Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products

    WK64938 the Calculation of Cleaning Validation Limits

    WK72293 Standard Guide for Definition of Combination Products (Drug / Device / Biologic Combinations)

    WK74514 Measurement of Particulate Matter in Pharmaceuticals using Automated Membrane Microscopy

    WK73465 Accelerated CMC development, manufacture and supply of therapies and vaccines for use in pandemics such as COVID-19

    0 matching WITHDRAWN standards under the jurisdiction of E55.03     E55 Home