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TITLE/ COMPANY | Issue Date | Status | Details |
---|---|---|---|
Test procedures is not scientifically sound and appropriate to ensure that raw materials, intermediates, and APIs, conform to established standards Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: The observation cites discrepancies in method verification, highlighting involvement of tech transfer issues. Excerpt: Your method verification/transfer Report confirmed use of two different batches contrary to SOP. View Details |
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. Cipla Limited |
21 Jun 2024 | Normal | Justification: Proper transfer of methods ensures continuity and consistency in testing across different sites. Excerpt: Test methods for numerous approved products were not appropriately validated/verified/transferred. View Details |