U.S. FDA Flags Two Procedural Lapses At Shilpa Medicare's Hyderabad Facility
Shilpa Medicare says it will work towards implementing corrective actions to address the FDA observations.
The U.S. drug regulator has flagged two procedural lapses at Shilpa Medicare Ltd.'s control testing facility, which is its analytical services division located in Hyderabad.
The Food and Drug Administration inspected the facility at Unit 7 in Nacharam from March 8 to 10. It was a good manufacturing practices inspection, the company said in an exchange filing dated March 11.
"The inspection is closed with two minor observations, which are related to improvements in existing procedures and are addressable."
The facility is involved in analytical testing of drug products, drug substances, raw materials and packing materials. It is also engaged in analytical method validations, method transfers and conduct of other miscellaneous studies. The facility is involved in the testing of the U.S., Europe and other markets' commercial batches, according to the filing.
"The company will be submitting the responses to U.S. FDA observations within stipulated timeline and will work towards implementing the corrective actions to address the observations," Shilpa Medicare had said in the filing.
This was the second U.S. FDA inspection on the site, it said. The initial inspection was done in April 2022, for which the GMP clearance (Establishment Inspection Report) was issued in July 2022.
BQ Prime has obtained a copy of the observations from the FDA:
Establishment of laboratory control mechanisms not drafted by appropriate organisational unit. There was a failure to validate deaeration or degasification process for dissolution media used during execution of dissolution test for some products. There was a failure to establish traceability of dissolution baskets that were used during calibration activities.
Established test procedures and laboratory control mechanisms are not followed, specifically failure to follow procedure of operation, cleaning and calibration of electrolab dissolution test with auto sampler.
The company is yet to respond to BQ Prime's emailed queries on the implications of the observations, any impact on existing revenues, steps being taken to address these issues and expected timelines for resolution.
Shares of Shilpa Medicare were trading 0.66% higher, as of 3:03 p.m., as compared with a 1.87% rise in the S&P BSE Sensex.