The FDA has slammed two Indian drugmakers — Emcure Pharmaceuticals and Lupin —for purported GMP violations.
A Jan. 27 to Feb. 4, 2015 inspection of Emcure’s facility concluded that the drugmaker had neither established nor followed proper written procedures to prevent microbiological contamination of products, according to a March 3 warning letter.
Specifically, the investigators said they observed poor aseptic processing techniques during the manufacture of injection USP. The letter cites violations such as an operator placing a cup on the floor of an ISO 7 area to collect water from a unit. In addition, operators were observed crawling on the floor during routine aseptic filling operations.
Inspectors also apparently saw operators wearing goggles on their foreheads and exposed skin before performing aseptic filling activities.
The letter also takes issue with the set-up of Emcure’s facility, as it may pose a contamination risk. It questions the adequacy of the video recordings the company sent in response to a Form 483 regarding design concerns. “Your response does not include an evaluation of all available videos to identify all batches that could be affected by poor aseptic practices and associated risks,” according to the letter.
Emcure’s environmental monitoring and personnel monitoring data are not reliable either, the letter says, due to scientifically unsound materials and procedures used to conduct data collection. It highlights dryness and desiccation in media plates used for surface and personnel monitoring.
The FDA also hits the company’s visual inspection program, noting that the operators were not qualified to detect and identify known product defects. Emcure said it would revise the qualification procedure for visual inspections in response to the Form 483, but apparently omitted the revised SOP.
Emcure also did not ensure that laboratory records included test data to assure compliance with established specifications and standards, the warning letter says. Specifically, records for active air monitoring of the aseptic filling area were reported as being collected even though they were not. The FDA says it discovered this data falsification through video recordings.
Lupin also is in hot water with the FDA after inspectors at the company’s Goa plant observed nine apparent GMP violations.
The inspection — which took place in early March — led agency inspectors to cite the company for failings such as “inadequacy and adherence” to standard operating procedures, according to the company.
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