EDQM suspends certificates for Chinese ingredients

The European Directorate on the Quality of Medicines has suspended the certificates of suitability (CEPs) of four active pharmaceutical ingredients manufactured in China.

Two benzylpenicillin APIs made by Chinese company Hebei Huari Pharmaceuticals, as well as dihydrostreptomycin sulphate and neomycin sulphate made by Sichuan Long March Pharmaceutical Co, are affected by the suspension.

The latest action follows a similar suspension in March which led to an ordered recall of 14 products by the Spanish Ministry of Health. That suspension concerned a CEP for clindamycin phosphate made by Zhejiang Pharmaceutical Co.

Other active pharmaceutical ingredients (API) made at the facilities are unaffected but blue inspection GmbH – a German company offering audits and inspections for starting materials and APIs for pharmaceutical clients - has advised companies to reassess products they receive from the plants.

Wolfgang Heisig from blue inspection, commented: “The EDQM auditors have obviously detected that these APIs are not manufactured according to the submitted documentation or in line with the requirements of ICH Q7” (the GMP Guide for APIs published by the International Conference on Harmonization).

EDQM can suspend the certificate  – which shows that the API meets the criteria laid out in the monograph contained in the European Pharmacoporia – if an inspection finds major deficiencies relating to Good Manufacturing Practice (GMP), a company refuses to allow an inspection, or the CEP itself is not kept up to date and current.

A CEP suspension is limited initially to a period of two years, according to a recently-published note for guidance on CEP suspensions available from the EDQM here.

Failure to meet the conditions to lift a suspension within that period, provided no justified extension of the suspension has been requested by the CEP holder and accepted by EDQM, leads to the final cancellation of the certificate.

A CEP that has been cancelled cannot be restored, so a new application has to be submitted should the sponsor want to reinstate it.