European regulatory authorities have finalized their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at Ranbaxy Laboratories’ manufacturing site in Toansa, India that had led to the suspension of the GMP certificate for the site in the European Union (EU).
Although the assessment showed that there were a number of GMP deficiencies at the concerned site, assessment of all available information has reassured European regulators that there has been no risk to public health from these deficiencies.
Patients should continue to take their medicines as prescribed by their healthcare professional.
European regulators also considered the corrective measures put in place by the company and were satisfied that the measures are sufficient to ensure GMP-compliant manufacture of products at the site. As a consequence, the EU authorities will reinstate the GMP certificate which was suspended in January 2014. The certificate will be re-entered into EudraGMDP, the EU database that contains GMP certificates.
The assessment followed an inspection by the U.S. Food and Drug Administration (FDA) which revealed areas of non-compliance with GMP at the site. The European medicines regulatory network responded quickly to the FDA’s findings, and sent a team of inspectors from Germany, Ireland and the UK, who were joined by inspectors from Switzerland and Australia to undertake an unannounced international inspection of the site.
The GMP inspection concluded that appropriate corrective and preventive measures have been put in place by the manufacturer. The inspection team concluded that there was no evidence that any medicines on the EU market that have an active pharmaceutical ingredient manufactured in Toansa were of unacceptable quality or presented a risk to the health of patients taking them. This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications.
European regulatory authorities have identified the need to keep the Toansa site under close supervision and this will be done in collaboration with India and other regulatory authorities around the globe.