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.

Regulation Handbooks: 21 CFR Part 210 & 211: Finished Pharmaceuticals
Guidance Docs

GMP Regulation Handbook: General, Finished Pharmaceuticals, 21 CFR Parts 210 & 211

Regulation Handbook: 21 CFR Parts 210 (General) & 211 (Finished Pharmaceuticals) Current Good Manufacturing Practice in Manufacturing, Processing...
Medical Devices and in Vitro Diagnostics Products 21 CFR Part 820
GMP Regulation Handbooks

GMP Regulation Handbook: Medical Devices, 21 CFR Part 820

Regulation Handbook: 21 CFR Part 820: Medical Devices Quality Systems Regulation (formerly known as Current Good Manufacturing Practice for Medical...
Regulation Handbooks: Electronic Signatures, 21 CFR Part 11
GMP Regulation Handbooks

GMP Regulation Handbook: Electronic Signatures, 21 CFR Part 11

The 21 CFR Part 11 regulation handbook is used in association with ISPE training courses. Attendees of the training course receive a complimentary...
Dietary Supplements, 21 CFR Part 111
GMP Regulation Handbooks

GMP Regulation Handbook: Dietary Supplements, 21 CFR Part 111

GMP Regulation Handbook 21 CFR Part 111 Code of Federal Regulations US Food and Drug Administration Current Good Manufacturing Practice (cGMP) in...
Active Pharmaceutical Ingredients, ICH Q7
Guidance Docs

GMP Regulation Handbook: Active Pharmaceutical Ingredients, ICH Q7

This GMP Regulation Handbook represents the FDA's current thinking regarding GMPs for manufacturing APIs under an appropriate system for managing...
Development & Manufacture of Drug Substances, ICH Q11
Guidance Docs

GMP Regulation Handbook: Development & Manufacture of Drug Substances, ICH Q11

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics...
Pharmaceutical Development, ICH Q8(R2)
Guidance Docs

GMP Regulation Handbook: Pharmaceutical Development, ICH Q8(R2)

Guidance for Industry, Pharmaceutical Development Q8(R2) U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...
Regulation Handbooks: Pharmaceutical Quality System, ICH Q10
Guidance Docs

GMP Regulation Handbook: Pharmaceutical Quality System, ICH Q10

Guidance for Industry Q10 Pharmaceutical Quality System. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...
Quality Risk Management, ICH Q9
Guidance Docs

GMP Regulation Handbook: Quality Risk Management, ICH Q9

Guidance for Industry, Q9 Quality Risk Management U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...