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U.S. FDA Flags Quality, Procedural Lapses At Biocon’s Hyderabad Facility


The U.S. drug regulator has flagged quality control and procedural lapses at Biocon Ltd.’s Hyderabad facility in a pre-approval inspection.

The U.S. Food and Drug Administration concluded a pre-approval inspection at Biocon’s active pharmaceutical manufacturing and method validation laboratory facility (Site 3) at Pashamylaram, Telangana, on July 20, the company had said in a July 21 exchange filing.

“Three observations were cited at the end of the inspection, which we will be addressing within the stipulated time,” it had then said, without disclosing any details.

A pre-approval inspection, according to the U.S. FDA, is performed to contribute its assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.

BQ Prime has obtained a copy of the observations from the FDA.

These are:

  • Deficient laboratory control mechanisms to ensure accuracy of raw data and back-up. Original electronic data for audit trails of analytical testing of drug substances was not available. Certain files could be located, reports provided were not true copies and there were certain inconsistencies in data records. There was also failure to provide injection log and original electronic chromatogram for exhibit batches for review.

  • Failure to monitor critical storage parameters that could potentially impact the quality of raw materials. Continuous temperature monitoring of the API finished good freezer and key starting materials freezer is not conducted due to lack of alarm system that can read and track it. Also, there is no segregation in the cold storage room that houses both approved and quarantine and rejected materials to prevent unintentional usage.

  • Standard operating procedures were not followed. The good manufacturing practices refresher training for employees was not conducted periodically as specified in procedures and qualification of suppliers of non-critical materials was not conducted since 2015 as a part of vendor management.

Biocon has yet to respond to BQ Prime’s emailed queries on the implications of the observations, the revenue contribution of the facility and impact on future approvals and launches. Also, the company is yet to comment on the steps being taken to address these issues and the expected timelines.

Shares of Biocon have fallen 6.14% since July 21.





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