Get Involved / Technical Committees / Committee E55 / Subcommittee E55.01 Standards

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


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      Showing Results 1-1 of 1 matching WITHDRAWN standards under the jurisdiction of E55.01     E55 Home

      E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)