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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 |
|---|---|---|---|
| Laboratory controls do not include the establishment of scientifically sound and appropriate specifications... Imprimis NJOF, LLC |
18 Aug 2026 | Normal | Justification: The observation highlights a critical lack of validated impurity detection methods, central to Method Validation. Excerpt: Your firm has not completed and implemented method validation for impurities and degradants for thirty-three... View Details |
| Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards Strides Pharma Science Ltd. |
20 May 2026 | Normal | Justification: The core issue arises from using unvalidated methods in microbial limit testing and identification, requiring method validation. Excerpt: Your microbiological identification method used for confirmatory identification of microorganisms has not been validated or verified for its intended use. View Details |
| The suitability of all testing methods is not verified under actual conditions of use. Bentley Laboratories LLC |
27 Mar 2026 | Normal | Justification: Method validation is directly linked with verifying the applicability of testing methods under actual conditions of use. Excerpt: Failure to ensure that the approved contract laboratory has performed method suitability of compendial methods... View Details |
| You have not ensured your microbiological methods are suitable for your operations. Fujifilm Diosynth Biotechnologies USA Inc. |
27 Mar 2026 | Normal | Justification: Method Validation is crucial to ensuring microbiological tests detect all relevant organisms and meet quality standards. Excerpt: You have not performed a risk assessment or evaluation to determine if your current bioburden methods of testing ... is suitable... 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 observation highlights the absence of method validation, which directly relates to 'Method Validation'. Excerpt: Failure to ensure that the approved contract laboratory has performed validation of the in-house method for Assay tests. View Details |
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