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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 |
|---|---|---|---|
| The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. Sato Pharmaceutical Co., Ltd. |
05 Jan 2026 | Normal | Justification: Method Validation is linked to the issue as the unidentified impurity suggests a lack of comprehensive validation and monitoring of impurities. Excerpt: HPLC chromatographic analysis did not monitor or report an impurity peak consistently eluting before the main peak. View Details |
| The suitability of analytical test methods is deficient for its intended use Ipca Laboratories Limited |
05 Dec 2025 | Normal | Justification: Method validation is crucial as the issue pertains to inadequate verification and lack of data supporting method accuracy. Excerpt: The site failed to provide any scientific data generated through a controlled study to demonstrate that the HPLC column temperate range of (b) (4) C to (b) (4) C can generate reproduceable and accurate results. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures Shilpa Medicare Limited |
21 Nov 2025 | Normal | Justification: The issue centers on method equivalency and validation, directly related to "Method Validation" in the test procedures. Excerpt: Your firm performed assays using both in house method and the compendial method and calculated relative standard deviation (RSD) for each method’s data. View Details |
| The written stability program for drug products does not include reliable, meaningful, and specific test methods. Shilpa Medicare Limited |
21 Nov 2025 | Normal | Justification: Method Validation ensures analytical methods comply with current standards and practices. Excerpt: Contracting laboratory revised their SOP for Analytical Method Validation/Verification. View Details |
| The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. Lupin Limited |
21 Nov 2025 | Normal | Justification: Method validation directly affects result reliability and is compromised if initial validation is inadequate. Excerpt: LC-MS/MS analytical test methods were validated ... observed sample test results of single batch were reported with variations. View Details |
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