GMP Publications - Code of Federal Regulation Handbooks by the FDA

Drug & Device GMP Desk Reference Set


Purchase Both as a complete desk reference set!

Regularly sold at $34.95 each, now get both for $ 49.90
Over 1900 pages of Regulations and Guidance to complete your library

 

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US FDA Title 21 CFR Parts

- Part 11 Electronic Records; Electronic Signatures with scope & Application
- Part 11 - Auditor's Check List
- Part 58 - Good Laboratory Practice
- Part 111 - Dietary Supplements GMPs
- Parts 210/211 Drug GMPs
- Parts 210/211 Drug GMPs - Auditor's Check List
- Part 820 Quality Systems Regulations
- Part 820 QSR - Auditor's Check List

Guidance

- ICH Q7 Active Pharmaceutical Ingredients (APIs)
- ICH Q7 - Auditor's Check List
- ICH Q8 - Pharmaceutical Development
- ICH Q9 - Quality Risk Management
- ICH Q10 - Pharmaceutical Quality System
- EU GMPs Chapter 1 – 9
- Canadian GMPs 2009 Edition GUI-0001
- Japanese GMPs

US FDA Title 21 CFR Parts

- 21 CFR Part 11 - Electronic Records; Electronic Signatures
- 21 CFR Part 801 - Labeling - Medical Device
- 21 CFR Part 803 - Medical Device Reporting
- 21 CFR Part 806 - Medical Devices; Reports of Corrections and Removal
- 21 CFR Part 807 - Estab. Reg. and Device Listing for Manuf. and Initial Importers of Devices
- 21 CFR Part 809 - In-Vitro Diagnostic Products
- 21 CFR Part 810 - Medical Device Recall Authority
- 21 CFR Part 812 - Investigational Device Exemptions
- 21 CFR Part 814 - Premarket Approval of Medical Device
- 21 CFR Part 820 - Quality Systems Regulations
- 21 CFR Part 821 - Medical Device Tracking Requirements
- 21 CFR Part 822 - Postmarket Surveillance
- 21 CFR Part 830 - Unique Device Identification

Guidance

- Medical Device QSIT Manual
- PMA Premarket Approval and 510 (k) Guidance
- Inspection of Medical Device Manufacturers Program 7382.845
- EU GMPs - Chapter 1 - 9
- Annex 11 Computerized Systems
- Annex 15 Qualification and Validation
- ICH Q8(R2) - Pharmaceutical Development
- ICH Q9 - Quality Risk Management
- ICH Q10 - Pharmaceutical Quality System
- General Principles of Software Validation
- Canadian Medical Device Regulations - SOR/98-282
- 98/79/EC In Vitro Diagnostic Medical Devices
- 93/42/EEC Medical Device Directive Updated 2007/47/EC September 2007
           

 

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