FDA cGMP Training Program课件.ppt

CGMP legal principles Excluded from the CGMP requirement Positron emission tomography, per FDAMA (own CGMP to be developed) Drug products compounded per Section 503 Pharmacy Compounding (FDAMA) CGMP Legal Principles Current = dynamic Standards evolve over time Good practices Minimal standards Not “best practices” Unless “best” is, in fact, current minimal CGMP Legal Principles Feasible and valuable No threshold for “percentage” in practice Doesn’t have to be “predominant” Enforceable even if nobody is doing it Stronger case if someone is doing it The CGMP Regulation CGMP for Finished Pharmaceuticals 21 CFR 210, 211 First issued: June 1963 Today’s version: September 1978 Scope Dosage forms for human/vet/biologics OTC, Rx, IND, NDA, Medical Gases Not: pharmacies, ingredients, non-clinical research, etc The CGMP Regulation CGMP for Finished Pharmaceuticals 21 CFR 210, 211 Substantive Force and effect of law Constitute major part of (not entire) CGMP more... The CGMP Regulation CGMP for Finished Pharmaceuticals 21 CFR 210, 211 Establish “what to” do, not “how to” do Minimal standards Maximum flexibility Specific enough to addressproblems e.g., Penicillin contamination control Technology neutral Scalable CGMP Implementation Tools Compliance Policy Guides Specific actions we do related to CGMP Examples: Sub Chapter 410 Bulk Drugs The regulations for finished pharmaceuticals will be applied as guidelines for bulk drugs Sub Chapter 420 Compendial (USP)/Test Requirements Ex:USP not required for release test Other Sub Chapters Labeling and Repackaging Stability/Expiration Process Validation Etc CGMP Implementation Tools CGMP Guidance Documents Principles: Not requirements Agency “current thinking” Detailed, technical Expression of “How to” meet “what to” do (requirements) Shape industry behavior offers routes to efficiency in meeting CGMP requirement, evaluation of compliance CGMP Implementation Tools CGMP Guidance Documents (Examples) General Principles of Proce