Subcommittee E55.13 on Process Evaluation and Control
Matching Standards Under the Jurisdiction of E55.13 by Status
- E1565-00(2019) Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures
- -See also WK94181 proposed Reapproval
- E1566-00(2019) Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen
- -See also WK94182 proposed Reapproval
- 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
- E3077-17e2 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
- -See also WK92361 proposed Revision
- 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
- WK76297 GMP Implementation of Advanced Process Control (APC) in Commercial Manufacturing
- WK92658 Evaluating the Risk of Cleaning Processes Using Process Capability
- WK85802 Performing Failure Modes and Effects Analysis on Cleaning Processes
- WK92936 Validating End-User Sterilizing Filtration of Pharmaceutical, Biopharmaceutical, and Biological Products
- WK92020 Raw Material electronic Goods Receipt and Release (eGRR) Data Transfer from Materials Suppliers to Pharmaceutical & Biopharmaceutical Manufactures
- WK82752 cGMP Best Practices for Combined Use Systems (medicinal product-device)
- WK92659 Performing Swab and Rinse Recovery Studies for Cleaning Validation
- WK86188 Risk Assessment of Cleaning Validation Programs