Good Distribution Practices in the Pharma Supply Chain - Focus on China
China's importance within the global pharmaceutical industry is growing. However, this growth requires a supporting infrastructure which allows pharmaceutical companies to transport drugs and related equipment in a safe, timely and cost-effective manner.
Henning Voss, director for World Courier, North Asia, described the challenges and situation in China as complex.
"In addition, domestic transport companies do not yet fully understand the many international standards at play in handling these types of shipments," Voss said.
To remain competitive in the global pharmaceutical industry the country is taking steps to improve the quality of its pharmaceutical supply chain. In January this year the Chinese State Food and Drug Administration (SFDA) published a newly revised Good Supply Practice for Pharmaceutical Products (GSP), which will go into effect as of June 1, 2013. The revised guidance sets higher qualification requirements, increases standards for drug distribution and also has higher requirements for quality management.
The revised GSP is made of four chapters, including the General Provisions, Quality Management for Wholesale of Pharmaceutical Products, Quality Management for Retail of Pharmaceutical Products and Supplementary Provisions.
The revised GSP means that many local pharmaceutical companies will need to lift their game when storing and handling drug products or they risk getting left behind their competitors
Charlie Xu, Vice President for Clinical Operations at Frontage Lab China said that compared to multinational companies, many local players don’t have stringent compliance records and the regulations are intended to raise the standards of GSP in the country.
"Good supply practices amongst local pharmaceutical companies are not great compared to international players. Unlike large companies, many smaller players don’t have in-built QAQC [Quality Assurance and Quality Control] systems," said Mr Xu.
To find out more about the revised guideline click here
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