FDA Regulations and Associated Guidance Documents: – Code of Federal Regulation Title 21 Overview – Part 11 Electronic Records; Electronic Signatures (21CFR§11) and Guidance for Industry – Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community (21CFR§26) – Part 200 Drugs: General (21CFR§200) – Part 207 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and The National Drug Code (21CFR§207) – Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General (21CFR§210) – Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (21CFR§211) – Part 600 Biological Products: General (21CFR§600) – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (21CFR§807) – Part 820 Quality System Regulation (21CFR§820) – Part 11, Electronic Records; Electronic Signatures — Scope and Application – Guidance for Industry and FD A Staff: Current Good Manufacturing Practice Requirements for Combination Products – Guidance for Industry: CGMP for Phase 1 Investigational Drugs – Process Validation: General Principles and Practices – PAT — A Frame work for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance – Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations – Contract Manufacturing Arrangements for Drugs: Quality Agreements – Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP – Formal Dispute Resolution: Sponsor Appeals Above the Division Level Reference Tools: – Glossaries combined in one location – GMP Keyword Index for 21CFR211 – Combined Index for all documents
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