Standards

ASTM E2363 - 06a Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

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

E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

E2537 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing

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

E2656 Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute

E2810 Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

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