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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 sampling plans and test procedures are not followed and documented at the time of performance Pharmathen International S.A. |
21 Nov 2025 | Normal | Justification: Sample management involves tracking and documenting sampling activities as substantiated by observation in environmental sampling records. Excerpt: Analysts were observed filling out the sampling information onto the paperwork during plate reading... View Details |
| The responsibilities and procedures applicable to the quality control unit are not fully followed. Lupin Limited |
21 Nov 2025 | Normal | Justification: Sample management issues are evident from missing reconciliation and unrecorded test details. Excerpt: Quality unit has not reconciled all the received and tested samples with corresponding test results and reports. View Details |
| Control procedures are not established which monitor the output and validate the performance UBI Pharma Inc. |
14 Oct 2025 | Normal | Justification: The observation describes insufficient detail in AQL sampling specifications leading to potential oversight in defects. Excerpt: SOP No. P801 Version 5 fails to specify how to collect vials, nor you record the locations. View Details |
| The adverse event of hypocalcemia occurred Hikma Pharmaceuticals USA Inc. |
23 Sep 2025 | Normal | Justification: Sample Management is crucial in clinical studies to ensure accurate and timely assessments of participant health, yet this may have been inadequately managed. Excerpt: The adverse event of hypocalcemia occurred in multiple subjects, yet was non-serious and not considered related to the study drug. View Details |
| OSIS conducted an inspection for clinical sites at Parexel Early Phase Clinical Unit and Nuvisan GmbH, Germany for study RGB-14-001 under BLA 761439. Hikma Pharmaceuticals USA Inc. |
23 Sep 2025 | Normal | Justification: The lack of documentation of subjects being supine before measurement relates to deficiencies in managing procedural documentation for sample processes. Excerpt: Lack of documentation that subjects were supine for five minutes prior to supine blood pressure measurement. View Details |
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