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Indian dominance of CEP suspension list reflects inspection policy says EDQM

By Gareth MacDonald+

21-Mar-2012
Last updated the 26-Mar-2012 at 12:04 GMT

Indian API manufacturers may dominate the list of companies that have had CEPs suspended this year, but that may say more about inspection policies than it does about standards outside Europe. 

According to its latest report the European quality watchdog suspended a total 7 Certificate of Suitability (CEPs) by the end of February following facility inspections, which is almost half the total number it pulled in 2011.

Mumbai-based Vital Health Care Pvt holds most of the suspended CEPs – some of which are still listed as active on its website at the time of publication – with fellow Indian producers Mehta API Pvt and Anek Prayog Pvt also holding one each.

European Directorate for the Quality of Medicines & Healthcare (EDQM) spokeswoman Fiona Gilchrist told in-Pharmatechnologist.com that: “The CEPs were suspended or cancelled following inspections carried out by EDQM, which evidenced non-compliance to EU GMP part II or to the dossier submitted.”

Vital spokesman Rajivi Bajaj confirmed this, telling in-Pharmatechnologist.com that his firm produces some of the active pharmaceutical ingredients (API) affected while stressing that the CEPs have been temporarily suspended rather than withdrawn.

The EDQM also suspended CEPs held by Chinese manufacturer Jilin Shuan Synthetic Pharmaceutical Co and one held by France’s Ergypharm – on the basis that neither firm was willing to undergo inspection.

And as for the consequences for Vital, Mehta, Prayong, Jilin and Ergypharm Gilchrist explained that the EDQM has informed the relevant authorities in all 36 member states of the Convention on the elaboration of a European Pharmacopoeia, as well as its observers and the European Union.

She added that: “We routinely inform the local authorities of the GMP non-compliance of the companies involed. It is then up to the countries to decide upon the concrete they take.”

Inspection selection

However, while it is undeniable that Indian producers dominate the list, this is not necessarily an indication that standards are lower outside Europe and may be more a reflection of the EDQM’s risk-based inspection policy as Gilchrist explained.

We hardly ever inspect manufacturers within the EU as these sites are normally covered by our partners, the EU inspectorates. This is the reason why the vast majority of CEP suspension or withdrawals relate to sites outside Europe.

Generally, we suspend all CEPs held by a company when their manufacturing site is shown non-compliant.” 

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