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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 Shilpa Medicare Limited |
21 Nov 2025 | Normal | Justification: Inspection revealed residue on equipment, indicating deficiencies in cleaning procedures linked to validation failures. Excerpt: Apparent residue observed on SMLJ 120 and SMLJ 141, documented as clean following validation cleaning cycle. View Details |
| Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination Baxter Onocology GmbH |
26 Sep 2025 | Normal | Justification: The observation highlights physical defects and residues on equipment, linking directly to Equipment Cleaning failures. Excerpt: There were scratches and gouges...peeling stickers...sealant...residue on...drips on the walls... 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 and cleaning and maintenance. Baxter Onocology GmbH |
26 Sep 2025 | Normal | Justification: The issues primarily stem from the equipment cleaning process failing to prevent biofilm buildup in the piping system. Excerpt: Equipment used is not of appropriate design to facilitate operations for its intended use and cleaning. View Details |
| Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination Fareva Amboise |
16 Sep 2025 | Normal | Justification: The observation directly discusses cleaning inefficiencies and residues on equipment, linking it to Equipment Cleaning process failures. Excerpt: There appeared to be residues on the gasket of the equipment. Analytical testing of the residue was identified to show the presence of the API. View Details |
| Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. Aurobindo Pharma Ltd. |
05 Sep 2025 | Normal | Justification: The observation indicates a fundamental issue with cleaning processes for equipment, which is directly aligned with Equipment Cleaning. Excerpt: The campaign length cleaning studies conducted... are not scientifically justified or defined. View Details |
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