EDQM suspends five more API certificates

Phil Taylor

25-Aug-2010

EDQM The European Directorate for the Quality of Medicines (EDQM) has suspended another set of certificates for active pharmaceutical ingredients (APIs) because their manufacturers have failed or refused inspections.

A Certificate of Suitability (CEP) is awarded by the EDQM if a company provides a declaration that it is making ingredients in accordance with Good Manufacturing Practice (GMP) and does not depend on a pre-approval inspection.

Once a CEP is granted the supplier can sell its product for use in medicinal products sold in the EU, and EDQM carries out periodic inspections of API manufacturing sites to make sure they are in compliance. The main issue is inspection capacity, as the agency can generally only inspect around 25-30 sites a year and relies on inspections by recognised regulatory agencies to plug the gaps.

Three of the five CEPs suspended in the latest round were assigned to Indian company Fleming Laboratories and followed inspections of the firm's manufacturing facilities in Secunderabad and Hyderabad. They relate to the APIs flunarizine hydrochloride for epilepsy, antihistamine cinnarizine and antidiarrhoeal loperamide hydrochloride.

Two further CEPs - both assigned to Chinese supplier Shandong Jinyang Pharmaceutical Co of Zibo City - have been suspended because of "a failure to comply with a declaration of willingness to be inspected and/or to operate according to EU GMP," says EDQM. The two CEPs are for the antidiabetic compounds chlorpropamide and tolbutamide.

The latest round brings the number of suspended or withdrawn CEPs in 2010 so far to 11, all from Chinese or Indian API manufacturers.

Related articles:

Danish plan to develop API audit guidelines draws criticism

EDQM launches track-and-trace pilot for medicines

EDQM continues clampdown on API manufacturers

EDQM suspends certificates for Chinese ingredients

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