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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 |
|---|---|---|---|
| Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination Strides Pharma Science Ltd. |
20 May 2026 | Normal | Justification: The equipment cleaning process is fundamentally linked as residues indicate the cleaning process was inefficacious. Excerpt: Residues were observed on the top of the HEPA filter housing...indicating a failure in the cleaning protocol. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established Emcure Pharmaceuticals Limited |
15 May 2026 | Normal | Justification: Residue accumulation on equipment directly implicates Equipment Cleaning processes. Excerpt: Multiple locations within ISO 5 had residues on surfaces, indicating cleaning failures. View Details |
| Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions Alkem Laboratories Limited |
01 May 2026 | Normal | Justification: The presence of rust and water droplets suggests leaks and improper cleaning maintenance, impacting Equipment Cleaning processes. Excerpt: Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination. View Details |
| (Repeat) Equipment and utensils are not cleaned, maintained at appropriate intervals Cerovene Inc. |
23 Mar 2026 | Normal | Justification: The observation detailed cleaning issues directly related to improper equipment cleaning processes. Excerpt: Presence of white caked residue in Capsule Machine ID and white powder inside validation locations. View Details |
| Written procedures are not followed for the cleaning and maintenance of equipment Bora Pharmaceuticals Injectables Inc |
20 Mar 2026 | Normal | Justification: Observation directly relates to the ineffectiveness of equipment cleaning procedures, as disinfectant residue compromises equipment sterility. Excerpt: The procedure indicates for equipment...to be wiped with (b) (4) following a (b) (4) disinfectant contact time; however, it is not effective in removing the disinfectant residue. View Details |
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