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Electrode, Comp-701311966, DC-prod-cdc03, ENV-prod-a, PROF-PROD, VER-19.1.31, SHA-771c9ce79737366b1d5f53d21cad4086bf722e21, CID-b0ab43f3-636-16e865a1e8c26c, Generated: Wed, 20 Nov 2019 01:08:03 GMT

Current Good Manufacturing Practices : Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents, Concise Reference, Second Edition

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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


Pharmalogika Books
Book Format
Original Languages
Number of Pages
Mindy J Allport-Settle
Publication Date
February, 2018
Assembled Product Dimensions (L x W x H)
9.02 x 5.98 x 1.38 Inches

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Electrode, Comp-389264356, DC-prod-cdc01, ENV-prod-a, PROF-PROD, VER-30.0.3, SHA-fe0221a6ef49da0ab2505dfeca6fe7a05293b900, CID-17919ed1-d29-16e8664027fd98, Generated: Wed, 20 Nov 2019 01:18:51 GMT