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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 |
|---|---|---|---|
| Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Grifols Diagnostic Solutions |
13 Mar 2026 | Normal | Justification: Without proper equipment cleaning validation, aseptic conditions cannot be ensured. Excerpt: There was no documentation to show that the cleaning and disinfection procedures had been validated for use. View Details |
| Control procedures are not established which monitor the output and validate the performance of those manufacturing processes. Maiva Pharma Private Limited |
20 Feb 2026 | Normal | Justification: The Equipment Qualification process failed to ensure that the Vial Inspection Machine operates as expected. Excerpt: The equipment failed to reject two defective vials identified by your firm as containing a fiber and a glass particle. View 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 |
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