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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 document and investigate Out of Specification results obtained by an unregistered facility Hetero Labs Limited, Unit-IX |
26 Sep 2025 | Normal | Justification: Supplier Quality Management is implicated due to the need for rigorous quality assurance practices with third-party service providers. Excerpt: It was observed at the unregistered testing facility the OOS results were obtained, only passing results were documented at your firm. View Details |
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity GenoGenix, LLC |
18 Jul 2025 | Normal | Justification: Supplier Quality Management is essential as the oversight of the supplier's analysis validity is lacking. Excerpt: Established the reliability of supplier analyses through appropriate validation of supplier test results at defined intervals. View Details |
Quality agreements are not established between (b) (4) facilities and (b) (4) Capricor, Inc. |
30 May 2025 | Normal | Justification: Supplier Quality Management involves overseeing supplier compliance to CGMP, which requires clear agreements on roles and responsibilities. Excerpt: no quality agreements have been established with multiple (b) (4) including the (b) (4) for (b) (4) at release, (b) (4) testing View Details |
Failure to check the reliability of Certificate of Analysis (COA) at Regular Intervals Krystal Biotech, Inc. |
30 Jan 2025 | Normal | Justification: Ensuring the reliability of supplier’s COA is a fundamental aspect of Supplier Quality Management to maintain material quality. Excerpt: Your firm has not established the reliability of suppliers COA through appropriate validation of the supplier’s test result. View Details |
There is a failure to thoroughly review any unexplained discrepancy SCA Pharmaceuticals, LLC |
20 Dec 2024 | Normal | Justification: Supplier Quality Management is crucial as the observation highlights inadequacies in dealing with supplier-caused material defects. Excerpt: Your firm continued to use them as container closures in your manufacturing activities. View Details |
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