GMP Regulation Handbooks

These handy booklets are an ideal way to keep everyone informed of FDA regulations and guidelines. They are an exact copy of the FDA documents.

Guidance Docs
Regulation Handbook: 21 CFR Parts 210 (General) & 211 (Finished Pharmaceuticals) Current Good Manufacturing Practice in Manufacturing, Processing,...
GMP Regulation Handbooks
The 21 CFR Part 11 regulation handbook is used in association with ISPE training courses. Attendees of the training course receive a complimentary...
GMP Regulation Handbooks
GMP Regulation Handbook 21 CFR Part 111 Code of Federal Regulations US Food and Drug Administration Current Good Manufacturing Practice (cGMP) in...
GMP Regulation Handbooks
Regulation Handbook: 21 CFR Part 820: Medical Devices Quality Systems Regulation (formerly known as Current Good Manufacturing Practice for Medical...
Guidance Docs
This GMP Regulation Handbook represents the FDA's current thinking regarding GMPs for manufacturing APIs under an appropriate system for managing...
Guidance Docs
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics...
Guidance Docs
Guidance for Industry, Pharmaceutical Development Q8(R2) U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...
Guidance Docs
Guidance for Industry Q10 Pharmaceutical Quality System. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...
Guidance Docs
Guidance for Industry, Q9 Quality Risk Management U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...