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The Complete U.S. & E.U. GMP Sterile Manufacturing Handbook for the Drug or Combination Device Industry:
The Complete U.S. & E.U. GMP Sterile Manufacturing Handbook for the Drug or Combination Device Industry:
FDA Regulations for Medical Devices - Starting at $4.95 each.
A must have for employees who work in the Medical Device industry. Includes requirements for Quality Systems and the Quality Management System
For Companies that manufacture Drug, Medical Device and Combination Products
FDA Regulations pertaining to Drugs and Medical Devices.
A must have for employees who work in the Medical Device industry. Includes requirements for Quality Systems and the Quality Management System
A great training and information tool providing employees with the CFR requirements for Drug, and Combination Products supporting OTC and Ethical manufacturing
FDA Regulations for Drug Manufacturing - Starting at $3.95 each.
Over 900 pages of GMP guidances and regulations to ensure your compliance is up to date! Includes US, EU, ICH, Canadian, Japanese and Chinese GMPs!
Over 450 pages of Regulations and Guidance. Great for CMOs and Drug Industry. A great training tool providing employees with the CFR requirements for Drug, and Combination Products supporting OTC and Ethical manufacturing
For Companies that manufacture Drug, Medical Device and Combination Products.
Over 900 pages of Regulations, Guidance and Checklists to keep you in compliance.
The Produce Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. Also available in
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Combination English / Spanish
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21 CFR Part 11 - Electronic Systems
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21 CFR Part 210/211 GMPs for Finished Pharmaceuticals
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ICH Q7 GMPs for APIs
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EU Annex 1 Sterile Drug 2023
Good Clinical Practices (GCP) Regulations for Drug Products - Last Updated 2024
Over 88 pages of GMP Regulations for the Human Food Industry. The requirements for food facilities to follow to ensure the safety and quality of human food.
A great training tool for the Dietary Supplement industry.
Over 300 pages of guidance and regulations to ensure your compliance is up to date!
Good Clinical Practices (GCP) Regulations for Medical Devices - Last Updated 2024
The Laws and Guidance supporting the Controlled Substance Industry under US DEA Requirements.
A great training and information tool providing employees with the CFR requirements for Drug, and Combination Products supporting OTC and Ethical manufacturing
FDA Regulations for Drug Manufacturing - Starting at $3.95 each.
10% Instant Coupon Code: GMP2026
Updated 21 CFR Part 820 QMSR 2026 Starting $4.95
820 QMSR with Auditor's ISO 13485 Correlation Checklist with Part 11.
$16.95.
Sale! - Drug & Device Master Guides
​Regulations - Guidance - Auditor's Checklists​
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Pharmaceutical Master Regulations - Now $24.95
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Medical Device Master - Now $24.95 Each
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Medical Device
Master Guide
Over 950 Pages
International
GMP Master
Over 950 Pages
