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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 |
|---|---|---|---|
| Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity Neeyaan LLC |
07 Aug 2026 | Normal | Justification: Process validation is essential for verifying that manufacturing processes achieve consistent product quality. The observation highlights a failure in conducting such validation. Excerpt: You failed to demonstrate your drug manufacturing processes are adequately validated. Additionally, you manufactured and released (b) (4) lots of (b) (4) USP tablets in 2025 intended for export. Your firm stated that no process validation was conducted for this product. View Details |
| OBJECTIVE 1e: The proposed commercial process and manufacturing batch record, including instructions Not available |
29 Jun 2026 | Normal | Justification: Process validation is essential for establishing the feasibility of manufacturing operations using scientifically justified data. The observation notes a lack of sufficient validation studies. Excerpt: At a minimum, data from Stage I process validation should be available. Evaluate Stage I process validation development studies and knowledge gained. View Details |
| OBJECTIVE 2: Conformance to Application Not available |
29 Jun 2026 | Normal | Justification: Validated processes must reflect application details to ensure product efficacy and safety. Excerpt: Verify that the manufacturing or processing methods are consistent with descriptions contained in the CMC section. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process Emcure Pharmaceuticals Limited |
15 May 2026 | Normal | Justification: The process type involves validating aseptic conditions effectively, which was not adequately performed as observed in the study. Excerpt: Procedures ... did not include adequate validation of the aseptic process. Multiple deficiencies were observed during the airflow visualization study. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process. Zydus Lifesciences Limited |
05 May 2026 | Normal | Justification: The observation highlights inadequacies in validating the airflow during sterilization, which is central to the Process Validation phase. Excerpt: The airflow visualization study did not demonstrate that airflow was unidirectional and free from turbulence. View Details |
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