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Major FDA Changes to the Drug GMPs (Effective 18 Dec. 2025)
21 CFR Parts 4, 16, 201, 210, 211, 213, 230, 314, and 514
Buy Now! Click on the book links below or www.gmppublications.com
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Warning Letters or FDA 483 Assistance
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Start-up Companies Requiring:
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Turnkey Readiness?
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Start-up Templates?
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Procedures?
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Mock FDA / EMA / ISO Inspections
GMP - GLP - GCP - GCLP - ISO 13485 QMSR
Drug, Medical Device, Dietary Supplements
FDA Readiness Assistance provided by the world's leading Consulting Support Group
Free* FDA GMP & QMS 8-hour Training
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GMP QMS 101 The Basics
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The GMP Lifestyle
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Predicate Rules
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The Agency, Inspections, Warning letters & 483s
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Quality Terminology
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The Quality Management System (QMS)
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The 11 General Orders / Principals of GMP
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21 CFR Part 11 Electronic Records
SME Time is Free - Hosted by John Cuspilich, Sr. Auditor
$29.95 Includes Registration fee, eWorkbook & eCertificate
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
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!
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.
Over 900 pages of Regulations, Guidance and Checklists to keep you in compliance.
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
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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
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
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.
Good Clinical Practices (GCP) Regulations for Drug Products - Last Updated 2024
Good Clinical Practices (GCP) Regulations for Medical Devices - Last Updated 2024
A great training tool for the Dietary Supplement industry.
Over 300 pages of guidance and regulations to ensure your compliance is up to date!
The Laws and Guidance supporting the Controlled Substance Industry under US DEA Requirements.
For Companies that manufacture Drug, Medical Device and Combination Products
FDA Regulations pertaining to Drugs and Medical Devices.
