{"product_id":"current-good-manufacturing-practices-pharmaceutical-biologics-and-medical-device-regulations-and-guidance-documents-concise-reference-second-edit-9781937258177","title":"Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents, Concise Reference, Second Edit","description":"\u003cp\u003e • Author(s): Kirstin a. Counts\u003cbr\u003e • Publisher: Pharmalogika Books\u003cbr\u003e • Publisher Imprint: Pharmalogika Books\u003cbr\u003e • BISAC: General\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eFDA 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\u003c\/p\u003e","brand":"Pharmalogika Books","offers":[{"title":"Paperback","offer_id":45535622430871,"sku":"9781937258177","price":4717.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9781937258177.webp?v=1767113950","url":"https:\/\/atlanticbooks.com\/products\/current-good-manufacturing-practices-pharmaceutical-biologics-and-medical-device-regulations-and-guidance-documents-concise-reference-second-edit-9781937258177","provider":"Atlantic Books","version":"1.0","type":"link"}