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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: Involves overall Laboratory Controls as the oversight of laboratory practices and error rectifications was insufficient. Excerpt: The firm invalidated the initial results and concluded...without adequate scientific justification. View Details |
| Test procedures relative to appropriate laboratory testing for pyrogens are not followed Eugia Pharma Specialities Limited |
06 Feb 2026 | Normal | Justification: The Laboratory Controls process type is implicated as the observed practice deviates from established protocols dictating handling of test samples. Excerpt: The SOP entitled, 'HANDING OF LAL REAGENTS AND BACTERIAL ENDOTOXIN TESTING BY GEL-CLOT TECHNIQUE' states that microbiologists are to 'gently mix the tubes' prior to incubation. View Details |
| Testing and release of drug product for distribution do not include appropriate laboratory determination Dr. Reddy's Laboratories Limited |
12 Dec 2025 | Normal | Justification: Laboratory Controls are directly linked as discrepancy in HPLC assay validation impacts the reliability of laboratory outcomes. Excerpt: Section 5.10.6 of your procedure, SOP-GLOB-QC-0085 requires (4) measurements from each preparation for assay test methods by HPLC. 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 issue directly concerns laboratory controls and sterility testing methods, which are pivotal for assuring drug product conformity. Excerpt: The method validation did not assess techniques to ensure the product could be effectively dispersed. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures Lupin Limited |
21 Nov 2025 | Normal | Justification: The observation highlights a failure in laboratory controls due to unreliable swab sample analysis methods. Excerpt: Analytical test procedures for swab sample analyses are not reliable to determine the level of active and degradant residual materials. View Details |
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