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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 |
|---|---|---|---|
| Established laboratory control mechanisms are not followed Eugia Pharma Specialities Limited |
06 Feb 2026 | Normal | Justification: A direct issue with Sample Testing as the OOS results arise from testing practices, necessitating revised procedural adherence. Excerpt: Approximately 35% of the invalidations of OOS results were recorded...57% attributed to analyst error and 18% to equipment errors. View Details |
| Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications Eugia Pharma Specialities Limited |
06 Feb 2026 | Normal | Justification: The observation highlights deficiencies in testing procedures that directly align with Sample Testing, affecting product quality. Excerpt: A demonstration of the firm’s destructive testing method was performed, and the visual operator was observed manually tapping the contents. View Details |
| Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy |
19 Dec 2025 | Normal | Justification: Sample Testing is crucial for verifying drug conformance to identity and strength; its absence directly impacts release procedures. Excerpt: Your firm does not conduct routine testing for potency (assay) for all drug products produced by your firm. 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: Sample invalidity due to small sample sizes points directly to issues within "Sample Testing" procedures. Excerpt: The sample size of (b) (4) ml for (b)(4) (b)(4) used during microbial examination... is not appropriate to derive a statistically valid number of colonies. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures Pharmathen International S.A. |
21 Nov 2025 | Normal | Justification: The observation details issues directly linked to sample testing practices, crucial for drug safety. Excerpt: Bubbles were observed between the (b)(4) and the media for (b)(4) samples. View Details |
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