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

Other Master Regulations and Guidance Handbooks - Pricing Discounts Available:

• 503B Outsourced Facility Compounding Master Guide

• Combination Products Master Handbook - For Drug/Biologics and Medical Device Products

• Good Laboratory Master Handbook - For Regulated GMP/GLP Testing Laboratories