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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 designed to prevent microbiological contamination of drug products purporting to be sterile are not established. Maiva Pharma Private Limited |
20 Feb 2026 | Normal | Justification: Preventive Maintenance is involved as it directly pertains to the maintenance of AHUs which affects pressure differentials. Excerpt: Your firm has not established and followed adequate written procedures to ensure maintenance of appropriate pressure differentials and airflow patterns during shutdown ... View Details |
| Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product. Aurobindo Pharma Limited, Unit VII |
10 Feb 2026 | Normal | Justification: The lack of preventive maintenance attention directly connects to the Preventive Maintenance process type issues. Excerpt: SOP No.: FU7-EN-MNP-007... has no mention of Quality Unit responsibilities... View Details |
| Critical material used to manufacture is not tracked, maintained, or replaced throughout their lifetime Lonza Visp |
28 Oct 2025 | Normal | Justification: Preventive Maintenance is implicated due to the absence of routine checks leading to reactive repairs. Excerpt: The product contact part of the (b)(4) is replaced; however, maintenance of the (b)(4) remains failure-based. View Details |
| Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and of adequate size FARMAKEIO OUTSOURCING LLC |
05 Sep 2025 | Normal | Justification: Preventive maintenance inadequacies can lead to equipment malfunction, causing product contamination risks. Excerpt: Your firm failed to include in the PM an inspection of the impeller shaft... View Details |
| Written sanitation and facility maintenance procedures are not established or followed Biocon Biologics Limited |
03 Sep 2025 | Normal | Justification: The lack of written notification or investigation into leaks is a clear Preventive Maintenance failure. Excerpt: No written notification or investigation into the leak until the current inspection. View Details |
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