China, Germany form global alliance for drug quality

12th June 2013 (Last Updated June 12th, 2013 18:30)

The Chinese Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) has signed a strategic co-operation contract with blue inspection body, the German Good Manufacturing Practices (GMP) third party auditor, to maintain drug quality.

The Chinese Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) has signed a strategic co-operation contract with blue inspection body, the German Good Manufacturing Practices (GMP) third party auditor, to maintain drug quality.

The alliance is designed to enable Chinese drug and active pharmaceutical ingredients (APIs) manufacturers to frame their quality management system (QMS) in compliance with the European GMP regulations.

blue inspection body managing director Dr Stefan Kettelhoit said that the initiative is expected to strengthen the global pharmaceutical supply chain.

"About 80% of the APIs, currently used for drug products in the European Union, are already nowadays sourced from China and other Non-EU-Member states. The related product quality is in the vast majority of cases excellent," Kettelhoit said.

Under the deal, GMP auditors from blue inspection body will introduce Chinese organisations to the specifics of the EU GMP regulations and differences to the China Food and Drug Administration (CFDA) standards.

Subsequent to a certification from the competent health authority, companies exporting APIs from countries such as China into the European Union are, from July, required to submit a written confirmation along with product deliveries.

Mock audits will also be conducted by blue inspection body at CCCMHPIE's member companies to allow the manufacturers to assess the extent of QMS compliance with the EU GMP regulations and make necessary adjustments.