“The initial statement of serious non-compliance permitted continued supply of critical APIs. Following a company decision to cease supply of API to the EU market, this statement of non-compliance was updated to cover all active substances in January 2015,” MHRA said in a statement on EudraGMP released Monday. The agency will require a re-inspection of the company’s Chikalthana, India site by an EU national competent authority prior to gaining approval to supply the EU market in future.
The blanket statement covering all of the APIs was added onto a GMP non-compliance report issued for the company’s Chikalthana site.
Data Integrity
Back in 2013, the US FDA hit the Chikalthana site with an import alert after the MHRA withdrew the site’s GMP certificate following non-compliance.
According to the MHRA’s inspection of the site from November 2013, “A critical deficiency was cited with regards to data integrity of GMP records, entries were seen to be made when personnel were not present on site, documentation was seen that was not completed contemporaneously despite appearing to be completed in this manner.”
The UK regulator also cited the company for potential product contamination, as well as “inappropriate pressure differentials that were not in line with the original design but had not been changed using change control, cleaning validation that was not sufficiently robust to confirm cleaning practices and maintenance issues, such as the failure to spark test glass lined reactor vessels for integrity especially following maintenance.”
The MHRA says the site manufactures high-blood pressure medicine Captopril, Oxybutynin HCI and Pramipexole Dihydrochloride monohydrate.
Wockhardt did not respond to a request for comment by press time, though a spokesman told an Indian newspaper that the company received clearance from the MHRA in December.
The statements made by the MHRA seem to indicate that the crackdown on Indian manufacturers by Western regulators will continue into 2015. Last year, Ranbaxy, Sun Pharma, Ipca and Amanta were all hit with warning letters or Form 483s following deficiencies, while already this year, the Italian Medicines Agency withdrew the GMP certificate of Sri Krishna Pharmaceuticals.