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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 describing the warehousing of APIs, Intermediates and raw materials are not established. Hetero Labs Limited (Warehouse) |
26 Sep 2025 | Normal | Justification: Temperature and humidity are mentioned as unmonitored in the storage description. Excerpt: B) there is no system or mechanism for monitoring warehouse temperature and humidity for APIs. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. Immacule Lifesciences Private Limited |
18 Sep 2025 | Normal | Justification: Improper sanitization before monitoring indicates foundational failures in environmental monitoring practices. Excerpt: Operators did not adequately sanitize RABs; sanitation procedures not followed before environmental monitoring. View Details |
| Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design Immacule Lifesciences Private Limited |
18 Sep 2025 | Normal | Justification: Environmental monitoring is lacking, as highlighted by the absence of non-viable particle monitoring during operations. Excerpt: No monitoring of non-viable particles during conveyor crossing, even though operators constantly enter and exit the LAFs. View Details |
| Aseptic processing areas are deficient regarding the system for monitoring environmental conditions Immacule Lifesciences Private Limited |
18 Sep 2025 | Normal | Justification: The observation highlights deficiencies in environmental monitoring efforts, crucial for ensuring aseptic conditions in processing areas. Excerpt: Your firm failed to conduct a scientific rationale for the (b)(4) non-viable particle counter (NVPC) locations. View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Immacule Lifesciences Private Limited |
18 Sep 2025 | Normal | Justification: The report's inadequacy indicates a flaw in monitoring processes that should safeguard sterile areas. Excerpt: Your Quality Unit does not produce comprehensive environmental trend reports of the controlled areas. View Details |
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