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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 |
---|---|---|---|
Your firm failed to establish an adequate written testing program to assess the stability characteristics of drug products. Center for Drug Evaluation and Research |
11 Jul 2025 | Normal | Justification: Stability Studies process type is directly linked to the issue as the oversight occurred in the execution of stability testing protocols. Excerpt: The stability studies conducted for Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/325 mg did not include testing for dissolution. View Details |
The written stability program for drug products does not include specific test methods. BSO, LLC |
27 Jun 2025 | Normal | Justification: Stability studies ensure drug products maintain quality over time. Missing tests (photostability, dissolution, impurities) affect this process. Excerpt: Stability Study BSO.SS.001 does not contain any data to demonstrate that the packaging protects the drug from photodegradation. View Details |
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Sun Pharmaceutical Industries Ltd. |
13 Jun 2025 | Normal | Justification: Failure in monitoring and responding to stability data trends directly affects the integrity of stability studies. Excerpt: Your Quality Unit did not investigate out of trend test results of an annual stability batch... View Details |
There is no written testing program designed to assess the stability characteristics of drug products. Stokes Healthcare Inc. dba Epicur Pharma |
23 May 2025 | Normal | Justification: The observation highlights a deficiency in the stability study, specifically related to impurity testing, a core component of Stability Studies. Excerpt: Stability study failed to test for impurities of Tacrolimus Ophthalmic Suspension including (b) (4) individual unspecified impurities. View Details |
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications Aurolige Pharma LLC |
10 Apr 2025 | Normal | Justification: Stability Studies processes were compromised due to inappropriate acceptance of sample results and unidentified peaks in analyses. Excerpt: During the review of analytical raw data mg Lot assay determination I observed an unidentified peak. View Details |
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