Subcommittee E55.03 on General Pharmaceutical Standards

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Showing results 1-11 of 11 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

    See also WK66032 proposed revision

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)

F838-15ae1 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

    See also WK70828 proposed revision

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

WK67425 Standard Practice Guide for the Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

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

WK59975 the Derivation of Health Based Exposure Limits (HBELs)

WK64938 the Calculation of Cleaning Validation Limits

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

0 matching WITHDRAWN standards under the jurisdiction of E55.03     E55 Home