EDQM takes issue with more Chinese APIs
pharmafile | May 5, 2009 | News story | Manufacturing and Production |Â Â Asia, ChinaÂ
The European Directorate on the Quality of Medicines has suspended the certificates of suitability (CEPs) of four active pharmaceutical ingredients manufactured in China.
The latest action follows a similar suspension in March which led to an ordered recall of 14 clindamycin phosphate products by the Spanish Ministry of Health.
To date there have been no reports of products recalled on the basis of the latest action, but health authorities are expected to carry out their own risk assessment based on the latest suspension in the coming weeks.
Two benzylpenicillin APIs made by Chinese company Hebei Huari Pharmaceuticals, as well as dihydrostreptomycin sulphate and neomycin sulphate made by Sichuan Long March Pharmaceutical Company, are affected by the suspension.
Other active pharmaceutical ingredients (API) made at the facilities are unaffected by the action, 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.
"The suspension of a CEP represents a serious action," said Dr Stefan Kettelhoit, a spokesman for the audit company.
He noted that the EDQM will have informed the European health authorities about the suspension, adding that "some of them, but by far not all, act as a result by initiating a recall on affected medicinal products in the respective country."
Some pharmaceutical manufacturers might face difficulties after suspension of a CEP, for example if their regulatory dossier is solely referencing this suspended CEP of the API supplier so they cannot source API from elsewhere, Kettelhoit said.
This type of action is usually taken by the EDQM if carries out a regulatory inspection and finds that the API manufacturer is not acting in compliance with the cGMP requirements as laid down in ICH Q7 regulations.
The EDQM can also suspend a CEP certificate if a company refuses to allow an inspection, or the information in the CEP dossier itself is not kept up to date and current.
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