Friday, December 9, 2016

10 Principles of GMP.




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. 

  1. Writing step by step operating procedures and working instructions. 
  2. Carefully following written procedure and instruction. 
  3. Documenting our work 
  4. Validating our work
  5. Designing and constructing facilities and equipment
  6. Maintaining Facilitates and equipment
  7. Defining, developing and demonstrating job competence 
  8. Protecting against contamination 
  9. Controlling component and product related process
  10. Conducting planned and periodic audit. 
"GMP MAKE IT A LIFE STYLE NOT  A REGULATION" 

Difference between Quality Assurance and Quality Control?


Quality Control


These are operational techniques and activities used to fulfill requirements for quality. So these are related to inspection, related to finding problem, related to finding problem and making sure that the defined standards or requirements are fulfill.

Quality Assurance

All the planned and systematic activities implemented with the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality. These are more of a preventive measure rather than inspecting and then acting on that. So these coming in the front and quality control comes at the late.

According to WHO " QA is a wide ranging concept covering all maters that individually and collectively influence the quality of a product".

QUALITY CONTROL
QUALITY ASSURANCE
Focus on product
Focus on process
Reactive
Pro-active
Line function
Stuff function
Find defects
Prevent defects
Testing
Quality audit