Chinese Chamber of Commerce for Import & Export of Medicines & Health Products signs co-operation contract with 3rd party GMP auditor blue inspection body
Beijing (China), Muenster (Germany), 11 June 2013 – Effective 01 June 2013, the China Chamber of Commerce for Import & Export of Medicines & Health Products (www.cccmhpie.org.cn) and the German Good Manufacturing Practices (GMP) 3rd party auditor blue inspection body GmbH (www.blue-inspection.com) form a strategic co-operation. Its primary goal is to support Chinese manufacturers of drug products and active ingredients (APIs) in the framework of their quality management system (QMS) to comply with European GMP regulations. “Through inspection of the adequate integration of EU-GMP standards into the QMS of manufacturers we want to strengthen the quality level and safety of the global Pharma supply chain”, underlines Dr. Stefan Kettelhoit, Managing Director of blue inspection body GmbH. CCCMHPIE is the leading and most influential national trade association in the Pharmaceutical and Nutraceuticals Industry. It represents more than 2,400 manufacturers and traders of pharmaceutical products. Being accredited by DAkkS for this purpose, blue inspection body GmbH examines the GMP compliance of pharmaceutical manufacturers of drug products and APIs around the globe.
Invited by the CCCMHPIE, GMP auditors from blue inspection body will introduce the specifics of EU GMP regulations and differences to the CFDA standards to Chinese enterprises. Effective July 2013, companies exporting APIs from third countries such as China into the European Union need to provide a so-called “written confirmation” along with product deliveries. Thereby the competent health authority of the exporting country needs to certify that the manufacturer at least complies with or exceeds the respective EU GMP standards. Dr. Stefan Kettelhoit stressed the fact that the alliance is not be regarded as a reaction to pharma supply chain scandals experienced in the past: “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.”
In addition, the member companies of CCCMHPIE will be offered to host so-called mock audits by blue inspection body. The Chinese manufacturers can thereby assess whether their QMS already complies with the EU GMP regulations or at which occasions the processes may need to be adjusted accordingly.
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Background information: blue inspection body GmbH
The blue inspection body GmbH examines the Good Manufacturing Practices (GMP) of pharmaceutical companies around the globe. Third-party audits by blue efficiently relieve manufacturing authorisation holders, API suppliers and API manufacturers. Blue inspection body GmbH is the first independent and accredited service provider for GMP audits in the European Union.
Background information: CCCMHPIE
The China Chamber of Commerce for Import & Export of Medicines & Health products (CCCMHPIE) was founded in May 1989 with the mandate to promote the development of international trade in medicinal and health products. CCCMHPIE represents one of the six major Chambers of Commerce under the Ministry of Commerce of China. The fields that CCCMHPIE cover ranges from Traditional Chinese Medicines (TCM), pharmaceutical & biopharmaceutical products, chemicals, medical devices and equipments, dressings, nutraceuticals, functional cosmetics to health products. The 2,400 plus membership covering almost all the leading pharmaceutical and health products manufacturers as well as medium sized enterprises and traders in China.