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Equipment Qualification
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Equipment and utensils are not cleaned at appropriate intervals to prevent... Granules India Limited |
06 Sep 2024 | Normal | Justification: The mention of inadequate cleaning since installation suggests deficiencies in initial and ongoing equipment qualification. Excerpt: Non-dedicated equipment used in the manufacturing of drug products at your firm have not been appropriately cleaned since their installation several years ago. View Details |
| Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. Empower Pharmacy |
28 Aug 2024 | Normal | Justification: Equipment Qualification issues are highlighted by scratches impacting aseptic nature of equipment. Excerpt: Scratches were observed inside ISO-5 hoods that do not appear smooth and cleanable. 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. ProRx LLC |
02 Aug 2024 | Normal | Justification: The observation explicitly mentions the lack of equipment qualification studies which is essential for ensuring equipment suitability and compliance. Excerpt: firm failed to perform protocol driven equipment qualification studies for the following equipment... View Details |
| Your firm failed to establish written procedures for production and process controls Biocon Biosphere Limited |
14 Jun 2024 | Normal | Justification: The issue directly pertains to the qualification of equipment (IQ/OQ/PQ), which is essential for ensuring they are suitable for their intended use in production. Excerpt: The process validation report titled "Process Performance Qualification Report of (b) (4) API" MVD-000146683, ver 3.0, was executed using equipment that was not fully qualified (IQ/OQ/PQ). View Details |
| Equipment qualification procedures are not followed Cipla Limited |
04 Apr 2024 | Normal | Justification: The observation directly relates to a failure in conducting required risk assessments and qualification activities for new equipment, pointing to a deficiency in executing the Equipment Qualification process as per the firm’s own standards. Excerpt: Your firm did not follow procedure 1035-G-0042 - Qualification of Equipment...for pharmaceutical ingredient manufacture...has not conducted a risk assessment nor qualification activities for the View Details |
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