Subcommittee E55.13 on Process Evaluation and Control | ASTM

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Subcommittee E55.13 on P…

Subcommittee E55.13 on Process Evaluation and Control

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Matching Standards Under the Jurisdiction of E55.13 by Status

E1565-00(2025) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
E1566-00(2025) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
E2629-20 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
E2898-20a Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
E3077-25 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
E3418-23e1 Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices
E3424-25 Standard Guide for Development and Validation Considerations of Advanced Process Control (APC) in Commercial Pharmaceutical Manufacturing
E3469-26 Standard Practice for Validating End-User Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products
E3470-25 Standard Guide for Using FMECA and HACCP for Performing Risk Identification, Risk Analysis & Risk Control on Cleaning Processes for Pharmaceuticals and Medical Devices

WK99028 Standard Guide for risk-based approaches to controlling visible particulate matter in the manufacturing of cellular therapeutic products
WK92936 Validating End-User Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products
WK92659 Performing Swab and Rinse Recovery Studies for Cleaning Validation
WK92658 Evaluating the Risk of Cleaning Processes Using Process Capability for Pharmaceutical Products and Medical Devices
WK86188 Risk Assessment of Cleaning Validation Programs