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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 |
|---|---|---|---|
| There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Zydus Lifesciences Limited |
05 May 2026 | Normal | Justification: Monitoring deviations in air velocity ensures environmental conditions remain within control limits. Excerpt: Large changes in the working height air velocities from initial and requalification studies were not investigated. 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. Maiva Pharma Private Limited |
20 Feb 2026 | Normal | Justification: The observation notes lapses in personnel monitoring, critical to controlling contamination during aseptic processes. Excerpt: No personnel monitoring is performed upon re-entry from Grade A to Grade B following such interventions. View Details |
| Batch production and control records do not include complete information relating to the production and control Gland Chemicals Private Limited |
27 Nov 2025 | Normal | Justification: Process monitoring lapses caused exceeding validated frequency of interventions, impacting process control. Excerpt: Corrective intervention frequency in media fill exceeded validated maximum. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. Shilpa Medicare Limited |
21 Nov 2025 | Normal | Justification: Observation highlights gaps in monitoring processes affecting process documentation quality. Excerpt: Interventions which occur during commercial manufacturing are not tracked or trended per container size. View Details |
| Records did not identify the person performing the work Americord Registry LLC |
17 Nov 2025 | Normal | Justification: Process Monitoring is key as tracking sterilization cycles and UCB status extends to process oversight and control. Excerpt: There are no utensil sterilization records documented including cycle temperature and duration. View Details |
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