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


    Showing results 1-6 of 6 matching ACTIVE standards under the jurisdiction of E55.01     E55 Home

    E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

        See also WK40198 proposed revision

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

    E2476-09 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

    E2629-11 Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems

    E2891-13 Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

    E2898-14 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

        See also WK45530 proposed revision

    Showing results 1-3 of 3 matching Proposed New Standards under the jurisdiction of E55.01     E55 Home

    WK12892 New Guide for Standard Guide for Process Sampling

    WK34349 New Guide for THE APPLICATION OF CONTINUOUS PROCESSING IN THE PHARMACEUTICAL INDUSTRY

    WK41265 New Practice for Sampling