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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 |
|---|---|---|---|
| Procedures for the maintenance of equipment used in the manufacture and testing of FAYUVI are not followed. Ultragenyx Pharmaceutical Inc. |
17 Sep 2026 | Normal | Justification: Equipment Qualification is linked, ensuring autoclave's reliable performance post-maintenance is critical for sterility. Excerpt: Potentially lead to equipment malfunction and impact the sterility assurance of aseptically filled products. View Details |
| Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program RC Outsourcing, LLC |
03 Sep 2026 | Normal | Justification: Equipment qualification is essential to verify proper equipment functionality. Omission of loaded-temperature mapping violates industry standards. Excerpt: Your firm has not performed temperature mapping under the worst-case conditions for your critical equipment during equipment qualification. View Details |
| The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products. Imprimis NJOF, LLC |
18 Aug 2026 | Normal | Justification: The failure in Performance Qualification approval directly links to Equipment Qualification process issues. Excerpt: Approving a PQ that structurally excluded the confirmed worst-case location identified by the firm’s own temperature mapping. 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: Missing equipment logs highlight a critical gap in ensuring equipment is qualified and used appropriately. Excerpt: No equipment logbook in place as per SOP ... 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: Missing equipment logs highlight a critical gap in ensuring equipment is qualified and used appropriately. Excerpt: No equipment logbook in place as per SOP ... View Details |
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