A global alliance has been formed between the Chinese Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) and blue inspection body, the German Good Manufacturing Practices (GMP) third party auditor, for drug quality.
The alliance seeks to allow Chinese drug and active pharmaceutical ingredients (APIs) manufacturers to make their quality management system (QMS) to comply 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.
The Chinese organisations will be familiarised with the EU GMP regulations and differences to the China Food and Drug Administration (CFDA) standards by blue inspection body's GMP auditors
Starting from July, APIs that are exported from China into the EU will have to submit a written confirmation along with product deliveries following the receipt of certification from the competent health authority.
blue inspection body will also carry out mock audits at CCCMHPIE's member companies to help them evaluate the expected QMS compliance with the EU GMP regulations.
