Pharmaceutical & Medical Device
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Standard Condensed Sterile Product Manufacturing Handbook
EU GMP Annex 1 Manufacturing of Sterile Medicinal Products (2023) with Parts 11, 210/211 and ICH Q7
GMP Manufacturing Handbook - Drug, Biologics, Vaccines & APIs -
Over 450 pages of Regulations and Guidance. Great for CMOs and GCP Industry.
NEW! Master EU GMP Annex 1 Mfg of Sterile Medicinal Products (August 2023)
- 21 CFR 210/211 - Drug GMPs - The basic GMPs for every Employee!
- 21 CFR Parts 210/211, Part 11 Electronic Systems and 820 QSR for Device
- 21 CFR 820 - Quality System Regulations
- 21 CFR Part 820, Quality Manual with Audit Checklist with ISO 13485 References
- 21 CFR 112 Produce for Human Consumption also in a combination English / Spanish
- 21 CFR Part 112 Produce for Human Consumption in both English and Spanish
- 21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook
- 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - GCP Medical Device Combination
- 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - IND/NDA Good Clinical Practice Handbook
- GMP International Pharmaceutical Master Reference Guide - Over 900 pages of Guidance and Regulations
- GMP Medical Device Master Reference Guide - Over 900 pages including EU Directive 2017/745
- Dietary Supplement Master Handbook - Includes Guides and Regulations for Supplements
- 21 CFR Part 117 - Food GMPs - Hazard Analysis, and Risk-Based Preventive Controls for Human Food