GMP is a system for ensuring that products are consistently produced and controlled according to quality standard. Basically it's design to minimize the risk of contamination, mix-ups and errors in any pharmaceutical industry and ensure the safety as well as potency of the product.
The heart of GMP is a well written procedure for each operation. This procedures minimized the Chances of mix ups and error in manufacturing. By following these procedure we not only ensure compliance with the GMP regulation but more importantly we ensure the consistent quality of the product.
Documentation should be made promptly and exactly and according to our written procedures. Importance of documentation is it's shows only that we have carefully and exactly followed the procedures.
Validation is a pro active proof that we can produce safe and effective product. It's requires a series of test to assure that our system and processes do what we say they do. It's also tell us our written procedure are correct and our product is truly safe and effective.
- Writing step by step operating procedures and working instructions.
- Carefully following written procedure and instruction.
- Documenting our work
- Validating our work
- Designing and constructing facilities and equipment
- Maintaining Facilitates and equipment
- Defining, developing and demonstrating job competence
- Protecting against contamination
- Controlling component and product related process
- Conducting planned and periodic audit.
"GMP MAKE IT A LIFE STYLE NOT A REGULATION"
