Quality Assurance

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hi to one and all,
I am Sudheer and i am working as a Chemist in Quality Assurance. I am a Trainee now and i want to know more details about the Quality Assurance and those topics related to Quality Assurance. My Questions are,

  1. What is Quality Assurance?

  2. Role & Significance of Quality Assurance in any Pharma/ API Industry?

  3. What is Stability? Importance, applications and significance of Stability?

  4. Why should we need to implement Good Manufacturing Practises only in the final stage of any API and why not to all the stages in the preparations of that API?

  5. Tell me the guidelines, and also refer me the books to get a good Knowledge in Quality Assurance?

Best Regards,

Sudheer.

2

dear sudheer ,

Read and grasp Q7 by ICH.

its is the bible for QA

rgds
srinivas