Ensuring Quality and Sustainability: A Deep-Dive of Our Couvet Site

Recently, WuXi AppTec’s Couvet site successfully passed another routine inspection by the US FDA. This recent achievement reaffirms our commitment to manufacturing excellence and strict adherence to global quality standards.

Located in Couvet, Switzerland, the “Couvet site” is a state-of-the-art drug product facility. It contains all onsite processes to manufacture, package, label, test and distribute product, including a robust quality control laboratory for incoming, release & stability testing. WuXi STA, a subsidiary of WuXi AppTec, provides customers flexible options to supply drug products to European markets and beyond.

The Couvet site has successfully passed major inspections by health authorities and is an approved manufacturing site in Switzerland, the United States, EU, UK, Japan, Australia, Canada and New Zealand. Notably, the Couvet site has been inspected three times by FDA in 2019 (PAI), in 2020 and in June 2023, all resulting in exceptional results: no 483 nor observation.

The results reflect the competence and expertise of Couvet site employees and their continuous commitment to maintaining the highest quality standards for patients. The strong collaboration and relationship between Quality and Operations teams is key to these achievements. Moreover, the partnership within WuXi STA sites across the globe allows the implementation of best practices to deliver a secure and robust drug product supply chain under one quality system meeting global standards.

Additionally, the site’s sustainability performance has garnered widespread recognition. In a recent accolade, the Couvet site received the silver medal in the 2023 business sustainability rating by EcoVadis with 68 points, further demonstrating WuXi AppTec’s commitments to Environmental, Social and Governance (ESG) initiatives. As a trusted provider of business sustainability rating, EcoVadis provides industry benchmarks, driving sustainability in global supply chains and encouraging industry-wide competence to achieve better global practice and continuous improvement.

Participating in this silver medal, the Couvet site is also recognized through ISO 14001 & ISO 45001 certifications. These international standards delivered by the Swiss Association for Quality and Management Systems (SQS) attest to state-of-the-art environmental, health & safety management systems supporting our sustainability performance.

These achievements and recognitions of the Couvet site are just part of WuXi AppTec’s efforts on strict adherence to the highest quality standards, and our commitment to better support our global customers. Moving forward, we continually strive for excellence, fostering collaboration with our partners to drive advancements and make a meaningful impact to patients worldwide.