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By PharmaCompass
2019-01-31
Impressions: 271 Article
The Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK has issued a statement of non-compliance to Indian drug maker Micro Labs Ltd’s manufacturing facility in Hosur (India).
According to the EDQM (European Directorate for the Quality of Medicines) website, the company failed an inspection held in November 2018, as it did not comply with the principles of good manufacturing practices.
MHRA is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
The inspection identified failures in the cross-contamination controls applied by the manufacturer. This resulted in a risk of cross contamination above Permitted Daily Exposure (PDE) from some products. The agency has withdrawn Micro Labs’ GMP certificates.
“MHRA would recommend consideration of recall of any products where manufacture followed low PDE products in equipment used for granulation, blending, compression,” the MHRA’s statement of non-compliance said.
“Only products critical to maintain patient supply to be supplied to EU markets whilst this statement of non-compliance remains in force,” it added.
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