Quotient Sciences, a leading global pharmaceutical drug development and manufacturing accelerator, is proud to announce the successful completion of an inspection and registration with the Chinese regulatory authority. This is the first inspection of its drug product manufacturing facilities in Boothwyn, Pa., USA (located on Chelsea Parkway) by the Chinese National Medical Products Administration (NMPA).
The NMPA, formerly known as the China Food and Drug Administration (CFDA), is China's regulatory body for drugs, medical devices, and cosmetics to ensure the safety of products for citizens of mainland China.
“The NMPA inspection of our Boothwyn facilities is a significant achievement for our company,” said Marlene Leuenberger, Vice President and General Manager of Quotient Sciences’ operations in Philadelphia. “There were no critical observations during the inspection, demonstrating our commitment to upholding quality and regulatory compliance as a trusted global partner to our biotech and pharma clients.”
During the inspection, the Chinese FDA reviewed the facilities, systems, and processes at the facilities. In addition to a general GMP inspection, a successful PAI (Pre Approval Inspection) for a client product and process was completed. The GMP facilities have previously been audited by the U.S. FDA (and others) over the past several years, however this was the first for the Chinese regulatory agency.
The 45,000 ft2 Boothwyn facility focuses on scale-up to late-phase manufacturing and commercial drug product supply. Both have HPAPI handling capabilities up to PBLEC 4.
In addition to drug product formulation and manufacturing, these two facilities are critical to the integrated Translational Pharmaceutics® drug development programs that Quotient Sciences conducts in the United States. Drug product manufactured at these facilities can be sent to Quotient Sciences’ clinical pharmacology facility in Miami, FL, where the company conducts Phase I studies with healthy volunteers.
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