Subcommittee E55.11 on Process Design
Matching Standards Under the Jurisdiction of E55.11 by Status
- E1564-00(2025) Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials
- -See also WK94180 proposed Reapproval
- E2475-23 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
- E2476-22 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
- E2500-25 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment Science and Risk Based Approach
- -See also WK88043 proposed Revision
- E2537-16(2024) Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing
- E2968-23 Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry
- WK78595 the Design of Clean in Place-Friendly Equipment for Pharmaceutical and Biopharmaceutical Applications (CbD Clean by Design).