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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 |
|---|---|---|---|
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Hetero Labs Limited, Unit-IX |
26 Sep 2025 | Normal | Justification: Using an unregistered lab without formal agreements points to deficiencies in assessing and managing quality risks. Excerpt: Unregistered laboratory is not referenced in any of your Drug Master Files (DMF) filed with FDA. View Details |
| The risk assessment for viral control at Dr. Reddy's Laboratories is inadequate Dr. Reddy's Laboratories, LTD, Biologics |
12 Sep 2025 | Normal | Justification: Quality Risk Management is relevant as the current risk assessment fails to identify and control critical viral contamination risks. Excerpt: The risk assessment for viral control is inadequate to mitigate potential virus cross-contamination risk. View Details |
| Failure to establish adequate specifications, sampling plans, and testing procedures to ensure that raw materials and APIs meet accepted quality standards Dr. Reddy's Laboratories (EU) Ltd. |
05 Sep 2025 | Normal | Justification: Failure to determine microbial testing requirements reflects a gap in risk management related to aqueous material use. Excerpt: Your firm should have conducted a risk assessment to determine appropriate microbial testing requirements. View Details |
| The responsibilities and procedures applicable to the quality control unit are not fully followed. Zydus Lifesciences Limited |
13 Aug 2025 | Normal | Justification: The observation highlights a failure in assessing and mitigating risks associated with product impurities, central to Quality Risk Management. Excerpt: market action for batches of US product that failed to meet the specification limit for Drug Substance Related Impurities. View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. GenoGenix, LLC |
18 Jul 2025 | Normal | Justification: The observation highlights failures in quality oversight, a core component of Quality Risk Management, impacting compliance. Excerpt: Your QU has not established control over: The release specifications of finished drug products. View Details |
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