GMP Manufacturing Handbook - Purchase Now!
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Sterile Product Manufacturing Pocket Handbook

NEW Annex 1 - 2023!

Perfect Training Reference for every Employee! Quality Discounts Apply!

21 CFR 210/211 - Drug GMPs - cGMP in Manuf., Processing, Packing, or Holding of drug and Finished Pharmaceuticals

21 CFR 820 - Quality System Regulations - Medical Device Quality Systems - Predicate Rules

For the other books below, save 10% by using Coupon Code: FDA2023-10

The Most Popular Handbooks! - Save 10% Today by using Coupon Code: FDA2023-10 Call for Details - 856-810-7331

21 CFR 210/211 - Drug GMPs - cGMP in Manufacturing, Processing, Packing, or Holding of drug and Finished Pharmaceuticals

21 CFR 820 - Quality System Regulations - Medical Device Quality Systems - Predicate Rules

21 CFR Part 117 - CGMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Food- Replaces Part 110 Food GMPs

21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination

21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - GCP - Good Clinical Practice Handbook

GMP International Master Drug Reference Guide- Over 900 Pages of International cGMP guidance and regulations

GMP Medical Device Master Reference Guide- over 900 Pages of cGMP guidances for the Medical Device Industry

The Master GMP Collection - Complete your Library Today!

International GMP Master Guide	Medical Device Master GMP Guide	Good Laboratory Practice Master Regulations	Good Clinical Practice Master Guide
Specifically designed for Drug Manufacturers, with over 900 pages of GMP Guidance and Regulations to ensure your compliance is up to date! Includes US, EU, ICH, Can. & Japanese Guidance and Regulations.	Specifically designed for Device Manufacturers, with over 900 Pages of Guidance and Regulations for the Medical Device Industry Medical Device Manual - Includes US Regulatonis and EU Directives.	A complete guide for Good Laboratoy Practice standards supporting GMP Non-GMP activities. Includes US Regulations along with 42 CFR Part 493 and OECD - General Principles of GLP Series 1	The 600+ page GCP Master Handbook is a complete reference library for the clinical professional. This handbook comes in a easy to carry 4.5" x 7.5" pocket size booklet for quick access to standards and references.
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Dietary Supplement Master Handbook	DEA Control Substance Master Regulations	Compounding Master Guide (503b) Facilities	Combination Product Handbook
Over 300 pages of GMP Guidance and Regulations specific to the Dietary Industry. Includes all of the US Regulations and Guidances.	Complete Guidance and Regulation pertaining to the Manufacturing, Holding, and Distribution of Controlled Substances.	Compounding and Outsourced Facilities Master Regulations and Guidance. Includes Drug GMPs 210/211 and all predicate rules and guidance.	You can also get the complete library for Combination Products: 21 CFR 3, 4, 11, 210/211, 820, ICH Q7, Definitions, FAQ's & GMPs for Combination Products Guidance
$22.95 - Qty Discounts	$26.95 - Qty Discounts	$22.95 - Qty Discounts	$14.95 each - Qty Discounts