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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 |
|---|---|---|---|
| Written documents are inadequate to ensure proper documentation and analysis of critical manufacturing operations Dr. Reddy's Laboratories, LTD, Biologics |
12 Sep 2025 | Normal | Justification: The observation shows a failure in ensuring process validation through comprehensive analysis, impacting sterility assurance. Excerpt: Report VALRP-BTO-002395 failed to provide a comprehensive analysis of the smoke study videos. View Details |
| Your firm failed to establish adequate written procedures for production and process controls designed to assure... Aurobindo Pharma Ltd. |
05 Sep 2025 | Normal | Justification: Process validation ensures the manufacturing processes yield a product meeting its intended specifications. This observation highlights lapse in achieving this. Excerpt: Process validations do not ensure critical parameters are challenged and validated ranges are not incorporated into batch records. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. AnazaoHealth Corporation |
08 Aug 2025 | Normal | Justification: Rigorous validation of hold times is critical for ensuring ongoing sterility of materials. Excerpt: No hold time study to support the expiration period assigned to depyrogenized glassware and utensils. View Details |
| Your firm failed to establish adequate written procedures for production and process controls AnazaoHealth Corporation |
08 Aug 2025 | Normal | Justification: Observation highlights deficiencies in process validation, crucial for ensuring uniformity and compliance. Excerpt: Process validation for the pellet products intended for implantation does not assess pellet-to-pellet content uniformity. View Details |
| There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Dr. Reddy's Laboratories Limited , FTO-11 |
18 Jul 2025 | Normal | Justification: OOS results were recurring, indicating poorly validated processes unable to ensure consistency. Excerpt: OOS results... were recurring in nature due to system failures. View Details |
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