WuXi Advanced Therapies (WuXi ATU) announced that it has successfully passed the European Union (EU) Qualified Person (QP) Audit and received the QP Statement supporting the facility in Wuxi City, China. This audit verifies that WuXi ATU’s Wuxi City site has effectively implemented the applicable requirements for GMP cell banking, plasmid manufacturing and quality control testing.

Specifically, this audit verifies that the Quality Management System (QMS) and the associated systems, including material, equipment, facility, utility, production, quality control and computerized system management at WuXi ATU’s facility in Wuxi City are operating per EU GMP standards and in compliance with Eudralex Volume 4 Part 1 – Basic Requirements for Medicinal Products and Part 4 – GMP Requirements for Advanced Therapy Medicinal Products.

The audit resulted in zero critical and zero major observations, a confirmation that this facility has the capability to provide high quality clinical and commercial manufacturing and CMC services to cell and gene therapy customers around the globe.

About the EU QP Certification
As outlined in Eudralex Volume 4 Annex 16 – Certification by a Qualified Person and Batch Release, “the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP)”. This requirement applies to medicinal products for human or veterinary use, as well as to investigational medicinal product (IMP).

The legal basis of Annex 16 is European Directive 2001/83/EC (human medicinal products) and 2001/82/EC (veterinary medicinal products), which clearly define the role, responsibilities, educational background and professional experience required to become a Qualified Person.

About WuXi Advanced Therapies
WuXi Advanced Therapies, a global Contract Testing Development and Manufacturing Organization (CTDMO), is the advanced therapies business unit of WuXi AppTec and offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies for customers worldwide. Our technologies, automation platforms and service solutions advance pre-clinical research and accelerate the timeline to GMP manufacture, while integrated GMP manufacturing and testing platforms reduce time to market, maintaining high titres, high levels of quality assurance and full regulatory compliance. Ultimately, our complete end-to-end solutions support pioneering companies to deliver breakthrough cell and gene therapies to the patients who need them. For more information, please visit https://www.advancedtherapies.com.