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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 fails to assure that the water system used in production areas provides consistent and uncontaminated water for API synthesis. Not available |
01 Aug 2025 | Normal | Justification: Neglect in maintaining the reverse osmosis system compromises the system's effectiveness and reliability. Excerpt: No preventative maintenance schedule or routine monitoring log available for the reverse osmosis system. View Details |
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination Sun Pharmaceutical Industries Ltd. |
13 Jun 2025 | Normal | Justification: The issue stems from failing to maintain equipment, which is directly tied to preventive maintenance neglect. Excerpt: The sealant that covered the cracks at the leaking areas appeared broken and missing sealant. View Details |
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination Aurolige Pharma LLC |
10 Apr 2025 | Normal | Justification: The lack of documentation following maintenance directly affects the cleaning process effectiveness, tied to Preventive Maintenance. Excerpt: No cleaning action was recorded in the Log Book following the preventive maintenance. View Details |
Equipment used in the manufacture of intermediates and APIs should be maintained in a good state of repair Zhejiang Huahai Pharmaceutical Co., Ltd. |
20 Nov 2024 | Normal | Justification: The observation directly states that preventive maintenance checks did not include inspections for material integrity, allowing degradation to go unaddressed. Excerpt: Your firm's equipment preventive maintenance records (PMs) show that a preventive maintenance check was performed ... and this deficiency was not addressed. View Details |
The firm failed to establish and follow adequate written procedures for the cleaning and maintenance of equipment Janssen Vaccines Corporation |
19 Nov 2024 | Normal | Justification: Preventive maintenance ensures equipment remains fit for use; unexplained residues signal a failure in maintenance checks. Excerpt: Maintenance records did not indicate any inspection or corrective action taken for the observed residues. View Details |
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