Good Manufacturing Practice (GMP) guidelines are for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
A List of GMP Guidelines in Pharma Industry
US FDA GMP Guidelines
- 21 CFR Part 210.: Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
- 21 CFR Part 211.: Current Good Manufacturing Practice for Finished Pharmaceuticals
European Union GMP Guidelines
- Good manufacturing practice
- Guidance on good manufacturing practice and good distribution practice: Questions and answers
World Health Organization Guidelines
- Medicines: Good manufacturing practices
- WHO good manufacturing practices for pharmaceutical products: Main principles
- WHO good manufacturing practices for the manufacture of pharmaceutical excipients
- WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug substances)
- WHO good manufacturing practices for pharmaceutical products containing hazardous substances
Australian GMP Guidelines
Canadian GMP Guidelines
PICS GMP Guidelines
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