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  • Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products
  • Committee E55 Subcommittees
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Subcommittee E55.01 on Process Understanding and PAT System Management, Implementation and Practice

Matching Standards Under the Jurisdiction of E55.01 by Status

Active 7 matching standards

  • E2475-10(2016) 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

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

  • 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

  • E3177-18 Standard Guide on Sampling for Process Analytical Technology

Withdrawn, Replaced 2 matching standards

  • E2474 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)

  • E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)

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