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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 |
| Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use Emcure Pharmaceuticals Limited |
15 May 2026 | Normal | Justification: The observation highlights deficiencies in Equipment Qualification, affecting product quality directly through suboptimal equipment performance. Excerpt: Your firm has not conducted any protocol-driven Performance Qualification (PQ) Studies with pre-approved acceptance criteria. View Details |
| Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. Zydus Lifesciences Limited |
05 May 2026 | Normal | Justification: Equipment Qualification is affected as the airflow visualization study directly pertains to validating the aseptic conditions around equipment use. Excerpt: The air flow visualization study ... was not conducted in accordance with a written protocol. View Details |
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