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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's quality control unit failed to exercise its responsibility Neeyaan LLC |
07 Aug 2026 | Normal | Justification: Traceability from raw materials to finished products was compromised due to inadequate procedures. Excerpt: Establishment of written procedures to ensure traceability of raw materials and in-process materials. View Details |
| Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications Neeyaan LLC |
07 Aug 2026 | Normal | Justification: Material Sampling and Testing processes are directly implicated as testing and verification of raw materials were inadequate. Excerpt: You failed to test samples of each component for identity...relying on supplier's certificate of analysis without establishing reliability. View Details |
| Each component is not tested for conformity with all written specifications for purity, strength, and quality. Strides Pharma Science Ltd. |
20 May 2026 | Normal | Justification: Material Sampling and Testing relates to the testing procedures that were not adhered to as per the observation. Excerpt: Your firm failed to perform (4) testing, including the limit test for (b)(4), on (b)(4) each shipment of each lot of high-risk drug components. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures Emcure Pharmaceuticals Limited |
15 May 2026 | Normal | Justification: Material Sampling and Testing directly influences how raw materials are verified for compliance per observation details. Excerpt: Your firm does not test the following raw materials for the limit of (b)(4), on each container individually... View Details |
| The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria. Novel Laboratories, Inc. d.b.a Lupin |
17 Apr 2026 | Normal | Justification: The observation specifically points out inadequacies in sampling procedures (SOP No. NL-QA-017.12) for high-risk components, linking to sampling and testing processes. Excerpt: The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria. View Details |
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