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Subcommittee E55.11 on P…
Subcommittee E55.11 on Process Design
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Matching Standards Under the Jurisdiction of E55.11 by Status
Active
6 matching standards
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
Proposed New
1 matching standards
WK78595
the Design of Clean in Place-Friendly Equipment for Pharmaceutical and Biopharmaceutical Applications (CbD Clean by Design).
Withdrawn, Replaced
0 matching standards
