China’s State Food and Drug Administration (SFDA) has released a revision of its good distribution practices guideline – which SFDA terms “good supply practices” (GSPs) – that will take effect at the beginning of June.
Firms will have three years to come into full compliance. After that time, non-compliant firms will no longer be able to ship pharmaceutical products into China. This is the first revision to SFDA’s GSPs in over a decade.
Work began conceptually on the updates in 2005, followed by an effort that formally began in 2009. A draft document was made available for public comment last spring.
According to SFDA, the revision “draws extensively on the World Health Organization, and the regulatory policies of the United States, the European Union and other developed countries and regions.”
The revised GSP contains 187 “articles” in four chapters covering: ● quality management ● supply chain ● computer system validation ● storage temperature and humidity monitoring ● pharmaceutical cold chain control ● quality risk management ● internal audits ● equipment validation ● documentation, and ● qualification of personnel.
According to SFDA, “the revised GSP sets higher qualification requirements and higher standards for engaging in drug distribution. Compared with the current GSP, the newly revised GSP has higher requirements for quality management, which will effectively enhance the capability to control drug quality risk in the distribution process.”