- CPC Passes 3rd US FDA Inspection
CPC Passes 3rd US FDA Inspection
CPC Scientific is pleased to announce that the Chinese Peptide Company (CPC) Good Manufacturing Practice (GMP) facility in Hangzhou, China has successfully passed its third U.S. Food and Drug Administration (FDA) inspection. No Form 483 observations were issued.
Passing this inspection is an important milestone for CPC Scientific and its GMP program. This official endorsement ensures potential GMP customers that peptides designed and manufactured by CPC Scientific have passed stringent requirements that demand excellence. As the world’s best-in-class provider of GMP peptides, CPC is compliant with current FDA cGMP standards.
“I am very happy with the outcome of this inspection,” said Dr. Shawn Lee, President and CEO of CPC Scientific. “CPC has established a rigorous quality system and EHS system in compliance with regulatory requirements of many regions including Europe, ICH, China, Japan, and WHO. Now we can proudly add this third successful U.S. FDA inspection to our growing list.”
“This inspection result demonstrates CPC’s commitment to regulatory compliance and, when 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 Stacie Schroeder, CPC Scientific’s Senior Vice President of Sales and Marketing.
CPC Scientific 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.
About CPC Scientific
With over 10 years of service to the peptide market, CPC Scientific manufactures quality custom peptides for research and clinical use. CPC Scientific and CPC comprise the CPC Group. The CPC Group is a trusted provider of high-quality, complex peptides for researchers and pharmaceutical companies worldwide. For more information, visit www.cpcscientific.com andwww.chinesepeptide.com.