The US Pharmacopeial Convention (USP) marked the official inauguration of its expanded laboratory and administrative facility in Shanghai, China.
“This is a tangible demonstration of the importance and value that USP and our counterparts in China place on assuring the quality of medicines, herbal medicines/dietary supplements and foods in China, the US and in all countries around the world,” said Roger L. Williams, MD, CEO of USP.
The expanded USP site in Shanghai features 95,000 ft2of space for laboratory facilities, which have been designed to address challenges related to product quality. Additional administrative space may be used foreducation, training, and allied activities. In addition to Shanghai, USP operates laboratories in Brazil, India, and Maryland.
“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.”
The pharmaceutical industry and the pharmaceuticals market in China are both growing rapidly, according to Williams. China is also a large and growing force in the production of generic drugs. China’s regulatory and compendial leadership has expressed its desire to advance modern, relevant standards for medicines and foods, and USP has joined in this effort via Memorandums of Understanding with Chinese Pharmacopoeial Commission, China’s National Institutes for Food and Drug Control, and the China National Center for Food Safety Risk Assessment. Given USP’s role in law in the US, where the current official versions of USP and the National Formulary are referenced and enforceable by the FDA, USP has also worked closely with FDA and its staff in China to advance good standards for foods and drugs.
“We live in an ever-shrinking world, which makes the quality of products made and sold in China just as important as the quality of products made and sold in the United States,” Williams said. “The global flow of products means that quality issues can have a wide impact and having a facility in China allows USP to work more closely with developments in this important industry.”