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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 designed to prevent microbiological contamination of drug products JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy |
19 Dec 2025 | Normal | Justification: The observation refers to non-qualified sterilizers, indicating equipment qualification deficiencies. Excerpt: Sterilization cycles used have not been initially validated or periodically verified. View Details |
| Control procedures are not established which validate the performance of those manufacturing processes Dr. Reddy's Laboratories Limited |
12 Dec 2025 | Normal | Justification: Equipment Qualification was bypassed after equipment replacement. Qualification ensures that equipment performs correctly. Excerpt: Your Head of Production stated that the working principles for (b) (4) are same thus requalification is not needed. View Details |
| The separate or defined areas and control systems necessary to prevent contamination Shilpa Medicare Limited |
21 Nov 2025 | Normal | Justification: The lack of equipment qualification after modifying critical gaskets links directly to Equipment Qualification processes. Excerpt: Equipment # SMLJ 051 gasket was modified without documented risk assessment or qualification. View Details |
| Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use UBI Pharma Inc. |
14 Oct 2025 | Normal | Justification: The linkage is evident as the observation centers on the lack of qualification for AQL testing and defect management. Excerpt: Review of the qualification report... confirmed that the was not qualified for the defect categories. View Details |
| Seamless unit diffusions expert parallel formulations prefacing situational outcome plans entrainable logically Hikma Pharmaceuticals USA Inc. |
23 Sep 2025 | Normal | Justification: The interchangeable nature of facilities suggests equipment use without full qualification for process integrity. Excerpt: Interchangeable underwriting facilities. View Details |
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