Subcommittee E55.13 on Process Evaluation and Control
Matching Standards Under the Jurisdiction of E55.13 by Status
Active 7 matching standards
Proposed New 6 matching standards
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WK64938 Calculating Safe and Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical Equipment and Medical Devices
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WK52609 Validating End-User Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products
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WK76297 GMP Implementation of Advanced Process Control (APC) in Commercial Manufacturing
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WK82752 cGMP Best Practices for Combined Use Systems (medicinal product-device)
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WK86188 Risk Assessment of Cleaning Validation Programs
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WK85802 Performing Failure Modes and Effects Analysis on Cleaning Processes