FDA Perspective on Process Validation for Biotech Products

ISPE Process Validation Conference 12 14 September 2017. Bethesda, MD. FDA Perspective on Process Validation for Biotech Products Zhihao Peter Qiu, Chief, Division of Inspectional Assessment Office of Process and Facilities Office of Pharmaceutical Quality FDA, Center for Drug Evaluation and Research Outline Overview of the 2011 Guidance for Industry Process Validation : General Principles and Practices Regulatory Requirements for specified biological Products submitted under Biologics License Applications (BLAs). An integrated CMC review and inspection for BLAs Overview of pre-license and pre-approval inspections Examples of 483 Observations/Case Studies 2. 1. ISPE Process Validation Conference 12 14 September 2017. Bethesda, MD. Statutory and Regulatory Requirements for Process Validation Section 501(a)(2)(B) of the Act (21 351(a)(2)(B)). A drug .. shall be deemed to be adulterated .. if .. the methods .. used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.

ISPE Process Validation Conference 12 –14 September 2017 Bethesda, MD 1 FDA Perspective on Process Validation for Biotech Products Zhihao Peter Qiu, Ph.D.

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