FDA inspection reveals cGMP issues at Biocon’s major Malaysia facility
pharmafile | March 13, 2018 | News story | Manufacturing and Production | Biocon, CGMP, FDA, pharma
Biocon’s insulin production facility in Johar, Malaysia – the largest integrated insulin manufacturing facility in Asia – has been slapped with six observations from the US FDA following an inspection which took place between the 6 and 15 February.
The observations identify areas where the facility’s operations deviate from current good manufacturing process (cGMP). Biocon currently has pending drug applications which are produced at the plant, including Insulin Glargine which is awaiting approval in the US, so its continued compliance with cGMP guidelines is key to its business.
The observations outlined by the FDA are as follows:
1. Procedures designed to prevent microbiological contamination of drug products to be sterile are not established or followed
2. There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed
3. Investigations of an unexplained discrepancy did not extend to other batches of the same product or other drug products that may be associated with the specific failure or discrepancy
4. Written production and process control procedures are not followed in the execution of product and process control functions
5. Laboratory controls do not include the establishment of scientifically-sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity
6. Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use
Biocon has said that it is currently in the process of providing an action plan of corrective and preventative measures to the US regulator.
Matt Fellows
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