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Broader quality management and more documentation of pharma logistics are the takeaways
The final versions of two GDP documents were issued recently, one by the European Union, and one by the Ministry of Health for China (MoH). China’s is called a GSP—“Good Supply Practices for Pharmaceutical Products,” but the MoH officials note that it encompasses GDP standards from Europe and the US.
The EU document, 2001/C, 68/01, comes out of a European Parliament directive from 2001 (2001/83/EC) and has been discussed and commented on fairly regularly since then, so there are few surprises. The main theme of the regulation is not so much technical as procedural: defining Responsible Persons for various stages in the transport of pharmaceutical products; training; and establishment of both quality management systems and documentation for them. Special attention is paid to brokers (those who trade in pharmaceuticals, but don’t take possession of them); in effect, the guidelines for design and operation of facilities don’t apply, but most other reporting and quality-management procedures do.
The China MoH document expresses many of the same intentions, including temperature management of cold chain products, quality management systems and training. The MoH authorities are also quite explicit: with some 13,000 wholesalers and 420,000 retailers in China, they want “business software and hardware requirements” that “suppress low-level redundant enterprises, promote structural adjustment of the industry and increase market concentration.”
The China document becomes effective on June 1, but there is a three-year adjustment period. The EU document is effective in six months.