《LPNORWOOD_PDA_Chptmtg_INDs_ComplyingwithcGMPSPhaseI》.pdfVIP

FDA Perspective on Approaches for Complying with CGMPS During Phase I INDs: Draft Guidance for Industry Laurie P. Norwood, M.S. Laurie P. Norwood, M.S. Chief/MRBII/DMPQ/OCBQ Chief/MRBII/DMPQ/OCBQ Center for Biologics Evaluation Center for Biologics Evaluation and Research and Research March 29, 2006 PDA Chapter meeting March 29, 2006 PDA Chapter meeting Overview: Regulatory Basis/Approach Regulatory Basis/Approach FDA CGMP Guidance FDA CGMP Guidance FDA Proposed and Direct Final Rule FDA Proposed and Direct Final Rule Draft Guidance: Developmental Draft Guidance: Developmental Principles Principles Draft Guidance: Scope Draft Guidance: Scope Draft Guidance: Recommendations Draft Guidance: Recommendations for CGMP Compliance for CGMP Compliance Regulatory Basis/Approach Drugs and biologics including Drugs and biologics including investigational new drugs are required to investigational new drugs are required to be manufactured in accordance with be manufactured in accordance with CGMPs CGMPs if not, considered adulterated [501(a)(2)(B) if not, considered adulterated [501(a)(2)(B) Food, Drug and Cosmetic Act] Food, Drug and Cosmetic Act] 21 CFR 210, 211 Current Good 21 CFR 210, 211 Current Good Manufacturing Practices for Finished Manufacturing Practices for Finished Pharmaceuticals Regulations [1978] Pharmaceuticals Regulations [1978] No specific regulations for API production No specific regulations for API production (Q7A GMP Guidance For Active (Q7A GMP Guidance For Active Pharmaceutical Ingredients [Adopted by FDA, Pharmaceutical Ingredients [Adopted by FDA, September 2001] ) September 2