EDQM continues clampdown on API manufacturers

The European Directorate for the Quality of Medicines (EDQM) has continued its scrutiny of active pharmaceutical ingredient (API) manufacturers around the world, suspending and withdrawing six additional certificates of suitability (CEPs) since the start of the year.

The actions provide another reminder of the importance of pharmaceutical manufacturers exercising care in the selection of API suppliers and auditing and monitoring them closely to ensure substandard or adulterated materials do not end up in finished medicines.

CEPs are submitted to the EDQM by raw material manufacturers who want to sell their products in Europe, and in essence provide certification that their ingredients are in line with the requirements laid down in the relevant monograph of the European Pharmacopoeia. Once a CEP is granted the supplier can sell its product for use in medicinal products sold in the EU.

EDQM undertakes periodic inspections of API manufacturing sites to make sure they are in compliance, typically around 25-30 a year, and also taps into inspections by recognised regulatory agencies. As a result of recent inspections it has suspended two CEPs and withdrawn another four.

The two suspended CEPs are for Albert David Ltd's chlorpropamide and tolbutamide, both made at the firm's manufacturing facility in Calcutta, India. 

The CEPs withdrawn by EDQM are three APIs from Indian manufacturer Vani Pharma Labs (metamizole sodium, prophenazone and phenazone) and zidovudine made by Chinese company Matrix Laboratories (Xiamen) Ltd.

Once a CEP has been suspended or cancelled, the holder has to inform its customers of the situation to allow them to take action related to any related marketing authorisations or applications.

The proportion of non-compliant sites identified by EDQM inspectors seems to be on the rise. In 2007 it was 18 per cent, rising to 21 per cent in 2008 and 34 per cent last year. Last year the agency inspected 29 sites - 16 in China, 10 in India, one in Europe and another in Asia - and found 10 sites that were non-compliant. As a result 10 CEPs were suspended and two were withdrawn.

At the time of writing, the EDQM's database of CEPs - which can be accessed here - includes 25 suspended certificates and 19 that have been withdrawn by the agency after being found no longer to be in line with regulatory standards.

Among the suspended CEPs, the majority (17) are from Chinese suppliers, with six from Indian manufacturers and one from a South Korea company. Meanwhile, seven of the 19 withdrawn CEPs came from Europe, eight were from India and four from China.


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