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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
E3106-22 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
E3219-20 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
E3263-22 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
