RE: validation Contribution from N H Eswara Prasad written on 8/2/2008 at 16:48
Original contribution: validation written by sonia on 7/19/2008 at 10:42) My dear
You should adopt Retrospective process validation for old batches which are not validated earlier.In this validation minimum of 20- 30 batches should be considered and there should not be any major changes in these batches.Generally regulatory will not accept the retrospective validation. My suggestion is intially generate the protocol for retrospective validation and compile the report and suggest for the procespective process validation.
For the cleaning validation - Refer APIC guidelines.
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