HANGZHOU, CHINA – March 17, 2016 – CPC Scientific Inc. is pleased to announce that the CPC Scientific Inc. Good Manufacturing Practice (GMP) facility in Hangzhou, China has successfully passed its fourth U.S. Food and Drug Administration (FDA) inspection. No Form 483 observations were issued.
Passing this inspection is an important milestone for CPC Scientific Inc. and its quality program. This official endorsement ensures potential GMP customers that peptides manufactured by CPC Scientific Inc. have passed stringent requirements that demand excellence. As the world’s best-in-class provider of GMP peptides, CPC Scientific Inc. is compliant with current FDA cGMP standards.
CPC SCIENTIFIC INC. serves GMP customers from early discovery stages through clinical trials, product development, and commercial manufacturing. Our fully-supported new chemical entity (NCE) development program includes process development, process validation, analytical method development, method validation, stability studies, regulatory support, and regulatory document preparation support. The production process incorporates an extensive series of tests to ensure that the resulting peptides meet customer standards.
“This inspection result demonstrates CPC Scientific Inc.’s commitment to regulatory compliance and coupled with our new facility expansion, shows that CPC is dedicated to building both facilities and quality systems for the future of the peptide market,” added Theresa Cheng, CPC Scientific Inc.’s Chief Business Officer.
“I am very happy with the outcome of this inspection,” said Dr. Shawn Lee, founder and Chairman of CHINESE PEPTID COMPANY. “CPC Scientific Inc. has established a rigorous quality and EHS system in compliance with regulatory requirements of many regions including Europe, China, Japan, ICH and WHO. Now we can proudly add this fourth successful U.S. FDA inspection to our growing list.”
