Retrospective Process Validation
Contribution from DR. SIRSENDU SUKUL written on 6/23/2004 at 11:32
My questions are regarding process validation in pharma industry. These are as follows -
1. Which official guideline will be followed for statistical analysis of data derived from a manufacturing process in pharma industry ?
2. Which Sigma Control Chart will be followed for process validation and why ?
3. Whether trend analysis is must or not for process validation ?
4. Which one we will use - Sigma Control Chart or X Chart or R Chart ?
5. Can we use five Sigma Control for process validation ?
6. What will be the critical control parameters for different processes like granulation, compression, coating and packing etc.?
7. What are the statistical tools for process validation ?
8. Is three Sigma Control is essential for process validation ?
9. Can we adopt higher Sigma Control Chart ?
10. If yes, where is the guideline / reference ?
11. Can we ignore Sigma Control Analysis ?
12. Can we ignore Upper Control Limit and Lower Control Limit as per standard books ?
11. How will critical parameters can be defined ?
12. Can we ignore trend analysis ?
13. If yes, what are the tools for retrospective validation ?
14. For implementation of WHO-GMP, which validation is/are must – prospective, concurrent or retrospective ?
Emcee Pharmaceuticals (P) Ltd.
S-10, Industrial Estate, Kalyani-741235, W.B.,India
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