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Use Process capability to Ensure Product Quality - …
1 Use Process capability to Ensure Product Quality Lawrence X. Yu, Director (acting) Office of Pharmaceutical Science, CDER, FDA FDA/ PQRI Conference on Evolving Product Quality September 16-17, 2104, Bethesda, MD 2 3 Quality by Testing vs. Quality by Design Quality by Testing Specification acceptance criteria are based on one or more batch data ( Process capability ) Testing must be made to release batches Quality by Design Specification acceptance criteria are based on performance Testing may not be necessary to release batches L. X. Yu. Pharm. Res. 25:781-791 (2008) 4 ICH Q6A: Test Procedures and Acceptance 5 6 Pharmaceutical QbD Objectives Achieve meaningful Product Quality specifications that are based on assuring clinical performance Increase Process capability and reduce Product variability and defects by enhancing Product and Process design, understanding, and control Increase Product development and manufacturing efficiencies Enhance root cause analysis and post-approval change management 7 Concept of Process capability First introduced in Statistical Quality Control Handbook by the Western Electric Company (1956).
1 Use Process Capability to Ensure Product Quality Lawrence X. Yu, Ph.D. Director (acting) Office of Pharmaceutical Science, CDER, FDA FDA/ PQRI Conference on Evolving Product Quality
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