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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 |
|---|---|---|---|
| Drug product expiration dates are not related to the storage conditions RC Outsourcing, LLC |
03 Sep 2026 | Normal | Justification: Stability Studies guide expiration determinations, and incomplete studies lead to unsupported BUDs. Excerpt: Stability testing is not conducted for its non-sterile compounded products. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate specifications... Imprimis NJOF, LLC |
18 Aug 2026 | Normal | Justification: Stability study protocols lack acceptance criteria, affecting assurance of product stability over its shelf life. Excerpt: No acceptance criterion exists, no result obtained during stability testing can constitute a stability failure... View Details |
| The written stability testing program is not followed. Mylan Laboratories Limited |
15 May 2026 | Normal | Justification: Stability Studies are linked because the oversight of placing annual stability batches is crucial for ensuring product quality over shelf life. Excerpt: No annual stability batches were placed for Tablets mg, representing batches manufactured in 2024. View Details |
| A Field Alert Report was not submitted within three working days of receipt of information concerning a failure Mylan Laboratories Limited |
15 May 2026 | Normal | Justification: The observation noted incomplete stability testing after the fire incident affecting product distribution. Excerpt: Your firm acknowledged that the fire incident has impacted testing of stability samples. View 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 |
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