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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 RC Outsourcing, LLC |
03 Sep 2026 | Normal | Justification: The inadequate establishment of testing specifications directly impacts laboratory controls, as seen in failed subvisible particle limits. Excerpt: Your firm continues to fail to provide a scientific rationale to support the established method and limits. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate specifications... Imprimis NJOF, LLC |
18 Aug 2026 | Normal | Justification: The observation specifically notes a lack of scientifically sound specifications and test procedures, directly implicating Laboratory Controls. Excerpt: Your firm was unable to provide scientific data or justification demonstrating that a release specification is appropriate... View Details |
| Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards Strides Pharma Science Ltd. |
20 May 2026 | Normal | Justification: Laboratory controls require validated and qualified methods to ensure test reliability and compliance. Excerpt: Your firm uses the (b)(4) system for confirmatory identification of microorganisms, using methods that are not validated. View Details |
| The responsibilities and procedures applicable to the quality control unit are not fully followed. Novel Laboratories, Inc. d.b.a Lupin |
17 Apr 2026 | Normal | Justification: The issue relates to inadequate laboratory controls over data management resulting from non-validated spreadsheets. Excerpt: These spreadsheets were observed to lack ... cell protection, audit trail functionality, and electronic signature controls. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate standards Bora Pharmaceuticals Injectables Inc |
20 Mar 2026 | Normal | Justification: The issue directly pertains to laboratory testing methods which are integral to Laboratory Controls. Excerpt: Specifically, A. The (b) (4) HPLC method lacks full optimization, accuracy, and robustness for its intended use. View Details |
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