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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 |
|---|---|---|---|
| The responsibilities and procedures applicable to the quality control unit are not fully followed. Ultragenyx Pharmaceutical, Inc |
19 Aug 2026 | Normal | Justification: Document management failure may result in outdated or missed procedural guidelines within the quality control unit. Excerpt: The responsibilities and procedures applicable to the quality control unit are not fully followed. View Details |
| The responsibilities and procedures applicable to the quality control unit are not writing or fully followed. Eugia Steriles Private Limited |
19 Jun 2026 | Normal | Justification: Lack of SOPs for various trials and missing justifications indicate weak document management processes. Excerpt: There is no standard operating procedure or written justification for the following trials... View Details |
| The responsibilities and procedures applicable to the quality control unit are not writing or fully followed. Eugia Steriles Private Limited |
19 Jun 2026 | Normal | Justification: Lack of SOPs for various trials and missing justifications indicate weak document management processes. Excerpt: There is no standard operating procedure or written justification for the following trials... View Details |
| Your firm failed to exercise controls over computerized manufacturing equipment Strides Pharma Science Ltd. |
20 May 2026 | Normal | Justification: Record-keeping failures stem from poor documentation practices, leading to non-traceability of manufacturing processes. Excerpt: Batch manufacturing records fail to consistently document the specific recipes used. View Details |
| There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Lonza Bend Inc. |
19 May 2026 | Normal | Justification: Missing documentation instances like unsupervised visual verifications indicate flawed document management processes. Excerpt: Operator...performed the visual verification of that gasket...documentation did not indicate... View Details |
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