Subcommittee E55.03 on General Pharmaceutical Standards


    Showing results 1-8 of 8 matching ACTIVE standards under the jurisdiction of E55.03     E55 Home

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

    E2503-13e1 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

        See also WK46216 proposed revision

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

        See also WK55465 proposed revision

    E2810-11e2 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

    F838-15a Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

    Showing results 1-3 of 3 matching Proposed New Standards under the jurisdiction of E55.03     E55 Home

    WK15778 New Guide for Science-based and Risk-based Cleaning Process Development and Validation

    WK51651 Standard Guide for Raw Material eData Transfer between Pharmaceutical & Biopharmaceutical and their Suppliers

    WK52609 Standard Practice / Guide for Validating End-user Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products

    0 matching WITHDRAWN standards under the jurisdiction of E55.03     E55 Home