Subcommittee E55.01 on Process Understanding and PAT System Management, Implementation and Practice

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Showing results 1-7 of 7 matching ACTIVE standards under the jurisdiction of E55.01     E55 Home

E2475-10(2016) Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

E2476-16 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

E2629-20 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

    See also WK71367 proposed revision

E2891-20 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

E2898-20a Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

E2968-14 Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry

    See also WK68728 proposed withdrawal

E3177-18 Standard Guide on Sampling for Process Analytical Technology

Showing results 1-2 of 2 matching Proposed New Standards under the jurisdiction of E55.01     E55 Home

WK41265 New Practice for Sampling

WK74957 PAT System Applications in Biopharmaceutical Industry

Showing Results 1-1 of 1 matching WITHDRAWN standards under the jurisdiction of E55.01     E55 Home

E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)