SUNNYVALE, Calif., April 6, 2016 /PRNewswire/ -- CPC Scientific is pleased to announce that the CPC 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.
To learn more about our GMP peptide manufacturing capabilities please visit: http://www.cpcscientific.com/custom-peptide-synthesis/cGMP-Peptide-Manufacturing/ and take a virtual tour of our facility at: http://www.cpcscientific.com/cgmp-video/.
Passing this inspection is an important milestone for CPC Scientific and its quality program. This official endorsement ensures potential GMP customers that peptides manufactured by CPC Scientific have passed stringent requirements and meet or exceed global regulatory requirements. As the world's best-in-class provider of GMP peptides, CPC is fully compliant with current FDA cGMP standards.
"I am very pleased with the outcome of this inspection," said Dr. Shawn Lee, President and CEO of CPC Scientific. "CPC has established a rigorous quality and EHS system in compliance with regulatory requirements in 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."
"This inspection result demonstrates CPC's commitment to regulatory compliance and high standards of quality. It also speaks to our ability to design and build our new state of the art GMP facility expansion to serve future global peptide markets," added Irvine Skeoch, CPC Scientific's Chief Operating Officer.
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.
Dr. Chris Gothard
CPC Scientific, Inc.
CPC is a trademark of CPC Scientific, Inc. in the United States. All rights reserved.
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SOURCE CPC Scientific