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

    E2537-08 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing

        See also WK46216 proposed revision

    E2656-10 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 1-5 of 5 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

    WK30195 New Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy

    WK46541 New Guide for for Specification, Design and Verification of Single Use Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.

    WK51651 Standard Guide for Raw Material eData exchange between Biopharmaceuticals and 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    0 matching WITHDRAWN standards under the jurisdiction of E55.03     E55 Home