SHANGHAI, CHINA, April, 12, 2021 – STA Pharmaceutical, a WuXi AppTec company (WuXi STA), a leading contract development and manufacturing organization (CDMO) announces that three of its sites in China have successfully passed pre-approval inspections (PAI) by the China National Medical Products Administration (NMPA) concurrently for an innovative drug from its partner. Following a successful PAI for Orelabrutinib with 4 sites inspected simultaneously a few months ago, this PAI is another comprehensive inspection for its integrated chemical, manufacturing, and control (CMC) platform for both drug substance and drug product, which once again proved WuXi STA’s industry-leading capabilities.
This comprehensive 13-day PAI involved three WuXi STA sites in China spanning drug substance process R&D (Changzhou), drug substance manufacturing (Shanghai Jinshan) and drug product R&D and manufacturing (Shanghai Waigaoqiao). During these 13 days, auditors conducted a comprehensive inspection of the development and manufacturing conditions for this innovative drug. All three sites successfully passed without major or key observations.
Since founded, quality has been WuXi STA’s lifeline and code of conduct. To establish specific quality system or general quality management system, WuXi STA abides by the highest global standards to ensure the quality of services to its partners worldwide. At present, WuXi STA’s quality system can support new drug applications in many countries and has successfully passed inspections from all major regulatory agencies including the US FDA, China NMPA, EU EMA and Japan PMDA. Received more than 200 client audits and 10 inspections from global agencies every year, WuXi STA keeps up a perpetual state of regulatory readiness, with real time GMP monitoring and an ingrained internal quality culture.
WuXi STA provides integrated and end-to-end CMC platform services to global partners. Currently, its pipeline carries more than 1300 new drug molecules, including 45 late-stage and 28 commercial projects. All sites of WuXi STA worldwide follow the same high quality EHS system to reduce risk, ensure quality and save time and cost for customers. The past PAI with four sites involved in 2020 and this three-site successful PAI are both direct result of this integrated quality system. In addition, the Marketing Authorization Holder (MAH) policy puts forward even higher requirements for quality system and product life cycle management. Following MAH, WuXi STA could start collaboration with customers at early development stage to ensure quality and compliance meet the needs of the product life cycle management.
Dr. Minzhang Chen, CEO of WuXi STA, commented: “I am very pleased that again we successfully passed PAI by the NMPA with multiple sites inspected at the same time. It is another track record for WuXi STA’s CMC platform capability and quality system. With the highest global quality systems and an in-depth understanding of global regulations, we strive to provide the optimal solution for each project of our partners, bringing more innovative therapies to patients faster.”
About WuXi STA
WuXi STA, a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses. For more information, please visit: https://sta.wuxiapptec.com/ and follow us on LinkedIn.
