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USP Inaugurates Expanded Shanghai Facility to Enhance Availability of Quality Standards for Medicines, Herbal Medicines/Dietary Supplements and Food Ingredients
Date:1/11/2014

sment (CFSA). Representatives of World Health Organization and the US FDA are also attending various events associated with the inaugural week.

Williams said the expanded USP site in Shanghai features 95,000 square feet of space for laboratory facilities which have been designed to not only address today’s challenges related to product quality, but also to evolve and grow as new issues emerge. Additional administrative space may be used for education, training and allied activities associated with USP’s core standards-setting work. In addition to Shanghai, USP operates laboratories in São Paulo, Brazil; Hyderabad, India; and at USP’s headquarters in Rockville, Md. (USA).

“Having a facility of this size and capability on the ground in China is extremely valuable, especially in a city like Shanghai, which has become a significant part of global pharmaceutical R&D and manufacturing,” said Williams. “This location will provide improved opportunities for USP to connect and communicate with Chinese-based manufacturers and regulators; expand training and technical outreach; work jointly on documentary and physical standards; translate USP’s compendia into Chinese; promote the value of visiting scientist programs and other cooperative efforts.”

Williams explained that the pharmaceutical industry and the pharmaceuticals market in China are both growing rapidly. China is also a large and growing force in the production of generic drugs. China’s regulatory and compendial leadership has expressed its commitment to advancing modern, relevant standards for medicines and foods, and USP has joined in this effort via MOUs with ChP, NIFDC and CFSA. Given USP’s role in law in the United States, where the current official versions of United States Pharmacopeia and the National Formulary are referenced and enforceable by the US FDA, USP has also worked closely with FDA and its staff in China to advance good standards for foods and drugs.

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