Subcommittee E55.03 on General Pharmaceutical Standards


    Showing results 1-6 of 6 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

    E2503-13 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

        See also WK46216 proposed revision

    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

        See also WK43140 proposed revision

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

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

    WK30195 New Guide for Particle analysis Applications in Pharmaceutical Processes including SUB-Visible particle analysis

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