Good Manufacturing Practices-GMP
GMP –Good Manufacturing Practice-is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients (Pharma GMP), pharmaceutical products (Pharma GMP) Foods Products (Codex GMP), Cosmetics (Cosmetic GMP) and Herbal Products (Herbal GMP).
Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing.
Ten Principles of Good Manufacturing Practice
1. Design and construct the facilities and equipments properly
2. Follow written procedures and Instructions
3. Document work
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures and work on instructions
7. Design ,develop and demonstrate job competence
8. Protect against contamination
9. Control components and product related processes
10. Conduct planned and periodic audits
Who should apply
Companies / Person(s) who import or manufacture pharma/cosmetic products, or have products imported or manufactured on their behalf are responsible for applying to the authority to have their products registered Our GMP Consultants with Pharma, Bulk Drug and Food Industry background will help in application of GMP Principles.