European regulatory authorities have finalized an assessment of reported non-compliance with GMP at Ranbaxy Labs’ manufacturing site in Toansa, India. While the assessment showed a number of GMP deficiencies at the site, European regulators concluded that there has been no risk to public health from these deficiencies. European regulators reviewed the corrective measures put in place by the company and found them to be sufficient to ensure GMP compliance, and, as a result, will reinstate the GMP certificate that was suspended in January 2014.
The assessment followed an inspection by the FDA, which revealed areas of non-compliance at the site. The European medicines regulatory network responded to the FDA’s findings, sending a team of inspectors from Germany, Ireland and the UK, along with inspectors from Switzerland and Australia to undertake an international inspection of the site.
The inspection team concluded that medicines on the EU market that have an API manufactured in Toansa were of acceptable quality presented no risk to patients. This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications.
European regulatory authorities will continue to monitor the Toansa site in collaboration with India and other regulatory authorities.