Quality Systems for Pharmaceuticals/Drugs in China

More and more Western pharmaceutical/drug companies are sourcing and/or manufacturing their pharmaceuticals/drugs in China. Hence, due diligence and appropriate quality standards are growing more and more important in China.

All Chinese drug manufacturers require Chinese GMP certification. This also includes manufacturers of IVD reagents, medicinal gas and cut crude drugs for Traditional Chinese Medicine (TCM). In addition, the State Food & Drug Administration (SFDA) recently implemented stricter regulations, including harsher consequences for problems discovered during GMP inspections. Foreign manufacturers should note that Chinese GMP is not equivalent to US FDA GMP.

As of now, the SFDA has not done physical inspections of drug manufacturing sites located outside of China. However, they have been training its inspectors in foreign standards and practices. The SFDA may start inspections of overseas facilities within a few years' time.

We can audit China drug manufacturers/suppliers to FDA standards.

For more information on Chinese pharmaceutical/drug quality issues, please see the following PBM publications and/or contact us to discuss your specific needs.

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