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Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components Alkem Laboratories Limited |
01 May 2026 | Normal | Justification: Issues stem from ineffective stability evaluations, allowing trends to be overlooked until significant failures occur. Excerpt: This batch failed again at 6-month long term stability timepoint due to individual unidentified impurity. View Details |
| Investigations of an unexplained discrepancy and failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product. Novel Laboratories, Inc. d.b.a Lupin |
17 Apr 2026 | Normal | Justification: Stability studies were not adjusted to monitor impacts of ingredient aging behavior. Excerpt: You did not place these batches on a stability program or conduct additional stability testing. View Details |
| The written stability program for drug products does not include reliable, meaningful, and specific test methods. Bentley Laboratories LLC |
27 Mar 2026 | Normal | Justification: The lack of meaningful and specific test methods affects the integrity of 'Stability Studies'. Excerpt: The written stability program for drug products does not include reliable, meaningful, and specific test methods. View Details |
| Results of stability testing are not used in determining appropriate storage conditions and expiration dates. Dr. J Skinclinic, Inc |
23 Mar 2026 | Normal | Justification: Stability Studies directly relates as stability testing should impact storage condition and expiration decisions. Excerpt: Results of stability testing are not used in determining appropriate storage conditions and expiration dates. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures Eosera, Inc. |
20 Mar 2026 | Normal | Justification: Stability study deficiencies highlighted by missing stability-indicating documentation. Excerpt: No documentation to show that the test methods used for stability samples are stability-indicating. View Details |
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