Successful Completion of Australia's Therapeutic Goods Administration (TGA) Audit
Washingtoner/10260490

SAN JOSE, Calif. - Washingtoner -- CPC announces the completion of a rigorous four-day audit conducted by Australia's Therapeutic Goods Administration (TGA), the country's government authority responsible for evaluating, assessing, and monitoring approved products defined as therapeutic goods. As a globally recognized peptide and oligonucleotide manufacturer, with our facilities built and operated to WHO GMP, FDA 21 CFR 210/211, and ICH Q7 standards, this audit marks a significant milestone in the company's ongoing commitment to ensuring the highest standards of quality and compliance. Our manufacturing facility in Hangzhou, China, was awarded an A2 compliance rating. This inspection certifies Good Manufacturing Practice (GMP) compliance of three commercial peptide active pharmaceutical ingredients (APIs). This achievement underscores our commitment to maintaining the highest quality standards in peptide production and ensures that our products meet stringent international regulatory requirements.

More on Washingtoner

• ExtraCarry Sponsors the World Revolver Championship
• Tacoma City Council Funds Pilot with St. Leo Food Connection to Expand Food Access at Tacoma Public Library
• Tacoma: Applications Now Being Accepted for three Positions on the Urban Design Board
• Spokane: Wildfire and Insurance Informational Session
• Premier Expands Presence with New Bellevue Flexible Workspace Location

About CPC Scientific.
Founded in 2001, we are the third largest peptide-focused contract research, development, and manufacturing organization ("CRDMO") worldwide in the of terms of sales revenue in 2023, according to Frost & Sullivan. We are also considered one of the most comprehensive peptide-focused CRDMO globally (Frost & Sullivan), offering complete life-cycle support from early-discovery, pre-clinical research and clinical development to commercial production.

Our operations in China are conducted in our facility located at No. 69, Street 12 of Qiantang District, Hangzhou ("Qiantang Site"), situated on our approximately 26,000 square meter CGMP campus. The constructed manufacturing CGMP facility has a gross floor area ("GFA") of over 15,000 square meters. Our production facilities adhere rigorously to CGMP as mandated by major regulatory authorities globally, including the U.S. Food and Drug Administration ("FDA"), National Medical Products Administration ("NMPA"), European Medicines Agency ("EMA"), Therapeutic Goods Administration ("TGA"), and Korean Ministry of Food and Drug Safety ("MFDA"). We have successfully passed four FDA audits without receiving FDA-483 observations (FDA notice highlighting regulatory violations found during an inspection) as of the Latest Practicable Date ("LPD"). In addition, our facility holds ISO9001 and ISO13485 certifications for quality management systems.

More on Washingtoner

• Haven Treatment Center In-Network with MODA Health, Expanding Access to Behavioral Health
• Cellofest Brings Free Cello Concerts and Community Events to Bethany Beach August 5–16
• Blue Sky Capital Strategies, LLC awarded Leasing and Financial Services agreement with Premier Inc
• Michael M. Thomas Expands Executive Leadership Across Central India Outreach and Royal Trinity School
• Northeast Airlines and Travel, Inc. Initiates FAA Part 121 Certification for Boeing 737-800 Freighter Cargo Operations

In addition to the Qiantang Site, we also have GMP production facilities under construction in the United States and Hangzhou, China, with a total GFA of 4,000 and 26,700 square meters, respectively. All our production facilities are equipped with advanced equipment and instrumentation supplied by top-tier equipment suppliers such as Agilent, Waters, Thermo Fisher, Cytiva, Jianbang, and Hanbang.

website