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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 purporting to be sterile are not followed Right Value Drug Stores LLC |
18 Jul 2025 | Normal | Justification: Smoke studies and personnel and environmental monitoring are critical in maintaining contamination control. Excerpt: Your firm failed to perform smoke study videos of the BSCs in a dynamic state. View Details |
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written. Dr. Reddy's Laboratories Limited , FTO-11 |
18 Jul 2025 | Normal | Justification: Contamination Control is linked as the SOP lacks instructions on sterilization, risking microbiological contamination of sterile products. Excerpt: Specifically, the SOP allows the use of non-sterile to clean surfaces and lacks prohibition for non-sterile material introduction. View Details |
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing. Right Value Drug Stores LLC |
18 Jul 2025 | Normal | Justification: Contamination control relies on regular needle changes to prevent particle generation, essential for drug safety. Excerpt: Needle replacement is performed specifically to reduce potential black particles (likely rubber coring or metal particles). View Details |
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established NATCO Pharma Limited |
19 Jun 2025 | Normal | Justification: The issue of microbiological contamination directly relates to contamination control, impacted by unqualified personnel and outdated procedures. Excerpt: Your firm does not have any employees fully qualified to perform 100% visual inspection activities on sterile drug products. View Details |
Equipment and utensils are not maintained at appropriate intervals to prevent contamination NATCO Pharma Limited |
19 Jun 2025 | Normal | Justification: The observation highlights failures in maintaining controlled environments essential for contamination prevention in aseptic processing. Excerpt: Damage on the wall above and below the clean room phone panel in the Grade A extended laminar airflow (LAF) area. View Details |
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