Links to GMP-Regulations

GMP Regulations

Pharmaceutical industry is regulated by health authorities of respective counties such as U.S. FDA, EMA, WHO, etc. GMP regulations are mandatory requirements as per law of respective country.

I have compiled the links of websites of various pharmaceutical regulatory agencies from where one can refer respective country regulations as well as guidelines.

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U.S. FDA and cGMP guidelines

1. e -CFR Part 210- Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs

2. e-CFR Part 211- Current good manufacturing practice for finished pharmaceuticals

3. Newly Added Guidance Documents

4. FDA Inspection Guides

5. FDA Warning Letters

6. FDA Guidelines for Biologics

7. FDA Guideline for Human Drugs

8. e-CFR Part 4 – Regulation of combination products

9. e-CFR Part 808, 812, 820 – Medical Device

10. Abbreviated New Drug Application (ANDA) Forms and Submission Requirements

11. Drug Master Files (DMFs)

12. ANDAs: Stability Testing of Drug Substances and Products

13. Process Validation: General Principles and Practices

Pharmaceutical Regulatory Affairs

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European Commission

EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines

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European Medicines Agency​

EMA Quality Guidelines

World Health Organization

WHO Pharmaceutical Guidelines

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MHRA

Medicines & Healthcare products Regulatory Agency

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CDSCO India

The drugs and cosmetics act, 1940 and the drugs and cosmetics rules, 1945

US Regulatory Affairs Summaries:

Where to find information on Drugs, Medical Devices, Biological Products, Cosmetics, Foods, Dietary Supplements, OTC, and IVD.

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