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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 |
---|---|---|---|
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design Right Value Drug Stores LLC |
18 Jul 2025 | Normal | Justification: Inadequate monitoring of environmental conditions directly relates to the Environmental Monitoring process type, affecting storage condition integrity. Excerpt: No scientific justification for the placement of the probe used to measure temperature and humidity in the DEA cage. View Details |
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed Right Value Drug Stores LLC |
18 Jul 2025 | Normal | Justification: Environmental monitoring outside critical contact areas fails to assure sterility in aseptic processing. Excerpt: EM sampling was performed outside of the operator's critical contact areas as defined by SOP 4.090. View Details |
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch NATCO Pharma Limited |
19 Jun 2025 | Normal | Justification: Environmental monitoring failures are linked to both inadequate investigations of new microorganisms and unperformed efficacy studies. Excerpt: A. Your firm did not perform a disinfectant efficacy study when a new microorganism was identified during an OOS investigation. View Details |
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. NATCO Pharma Limited |
19 Jun 2025 | Normal | Justification: Environmental Monitoring is central to this issue due to discrepancies in monitoring non-viable particles and adherence to procedures. Excerpt: Environmental monitoring for non-viable particles (NVP) during aseptic operations was found to be inadequate. View Details |
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed Sun Pharmaceutical Industries Ltd. |
13 Jun 2025 | Normal | Justification: The inability of current monitoring systems to accurately capture critical contamination points indicates flaws in environmental monitoring practices. Excerpt: Environmental monitoring personnel moved through the conveyor, compromising the aseptic zone. View Details |
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