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Regulatory Focus™ > News Articles > China Issues Revised GSP Guidance for Cold Chain Quality Control

China Issues Revised GSP Guidance for Cold Chain Quality Control

Posted 31 October 2013 | By Louise Zornoza

China's Food and Drug Administration (CFDA) recently issued revised Good Supply Practice (GSP) guidance for pharmaceutical cold chain quality control requirements that addresses computer systems, automatic temperature and humidity monitoring, drug delivery and acceptance and validation management. 

In issuing the revised guidance on 23 October 2013, CFDA said it draws extensively on the drug distribution regulatory policies of the World Health Organization (WHO) and "some developed countries and regions."  The agency also drew on China's pharmaceutical good manufacturing practice (GMP) experience, keeping in mind that the overall infrastructure for management of pharmaceutical distribution in the country is weak. 

CFDA acknowledged that implementation of the proposed new management measures and new technical requirements, while necessary, will not be easy.

CFDA: GSP Guidance

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