China API Firms Knowledge of EU CEPs "Good on Paper" says Audit Firm

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Blue inspection body, European directorate for the quality of medicines, Council of europe, European pharmacopoeia, Edqm

Chinese CEP Knowledge "Good on Paper" says Audit Firm
Chinese CEP Knowledge "Good on Paper" says Audit Firm
Chinese understanding of European CEPs is good, but some manufacturers are still unclear on the related obligations and requirements according to auditing firm, blue inspection body.

This week European Directorate for the Quality of Medicines and HealthCare (EDQM) representatives met Chinese manufacturers in Shanghai to discuss impurities in drug actives and gauge knowledge of European Pharmacopoeia certificates of suitability (CEP) system.

Attendee Stefan Kettelhoit, managing director of blue inspection body GmbH, told that: “In my view, the range of knowledge [of CEPs in China] is broad, from fairly basic to well understood and established​”.

It was very interesting to note that obviously the “paper part” of the CEP is well understood, but the related obligations and consequences concerning inspections seemed not to be clear to the full extent for the companies​.”

To address this, he continued, the EDQM stressed the importance of continuous good manufacturing practices (GMP) compliance - “expect, if you have been inspected, that another inspection will take place​” – and underlined that one passed inspection does not mean subsequent assessments will also be successful.

Despite this, the overall outcome of the meeting was positive according to Kettelhoit who said he had been “impressed about the interest, dedication and willingness to learn shown by the participants.​"

CEP development

That the EDQM is in China discussing quality issues with manufacturers is also good news in Kettelhoit’s view, who suggested that it shows the organization’s commitment to further developing the CEP system.

This was quite evident with the topic “control of impurities” but also with the topic ‘definition of starting material” ​he said, adding that “the EDQM no longer accepts any non-basic/non-commodity material such as ‘crude API’ or “complex heterocycles” as starting materials without proper GMP compliance control.”

blue inspection body started working with conference’s organizer, the China Chamber of Commerce for Import & Export of Medicines and Health Products (CCMHIP), in June​ to help Chinese API firms prepare for new EU import requirements.

At the time the Munster, Germany-based organization predicted that some Chinese manufacturers would not have the written quality confirmations necessary to ship to Europe.

The audit company is more confident about their acceptance of both CEPs and the recently introduced impurities guidelines for antibiotic APIs​ that are produced via fermentative processes.

Kettelhoit said: “I think that the API manufacturers and Chinese authorities are quite well prepared in the meantime. Therefore I do not expect major shortages​.”

He also predicted that growing Chinese interest in European regulations would be good for business, explaining that: “This seminar was definitely an interesting starting point within our CCCMHPIE cooperation for, informing potential customers, explaining our business and for winning more auditing work in the mid – long term​.

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