The quality is of the utmost importance in the pharmaceutical and life sciences industry. A report of the development of medicines or production quality can have catastrophic consequences that directly influence human lives. This in -depth responsibility makes a relentless dedication to quality an ethical necessity, for which every step is insured, from research to production, adheres to the highest standards for public health.
Wuxi AppTEC (https://www.wuxiapptec.com/), A leading global CRDMO, supports thousands of partners in more than 30 countries in their mission to deliver breakthrough treatments. Its vision, “any medicine can be made and any disease can be treated”, to realize this vision in a responsible manner, effective treatments must first be manufactured safely, reliable and consistently. This means that quality must be the absolute basis, so that every scientific progress is translated into a safe and reliable therapeutic for patients.
At the same time, as Global New Drug R&D evolves into a more efficient and fast model, CXOS are increasingly involved in the new development process of medicines. Wuxi Apptec, a globally renowned CRDMO company in the pharmaceutical and health care industry, has continuously extended its worldwide facilities over the years to meet the growing R&D requirements. This has further accelerated the drugs of customers that enter global markets, while also means that the quality and compliance systems of Wuxi AppTEC must meet the stringent requirements of different countries and regions worldwide.
The company consistently complies with the highest worldwide quality and regulatory standards in all activities, from purchasing raw materials to R&D, production and quality management. It has a proven track record of successfully passing on inspections by large global regulatory authorities, including the American FDA, EU EMA, China NMPA and Japan PMDA. More than 80% of the main facilities are certified for GMP, GLP, GCP, ISO 9001 and ISO 13485.
Demonstrable success in global legal audits and certifications
Couvet, Switzerland: this site specialized in clinical and commercial scale oral fixed dosage production, has a flawless record of No Form 483S nor observations from three FDA inspections (2019, 2020 and June 2023). This record “No 483S” is a gold standard, which means a deeply built -in, proactive quality culture. The site also reached ISO 14001 and ISO 45001 Recertification in 2024 and supplies products to large world markets.
Munich, Germany: This site has successfully approved the GMP inspection by the German BFARM and achieved its production/import authorization (MIA) and EU-GMP certification. This launched Wuxi Apptec’s EU qualified person (QP) Release services, simplifying import procedures and accelerating patient access to the EU.
Changzhou and Taixing, China: these two API production locations have successfully passed on the American FDA inspections in March 2025, both without a single observation and without form 483. The API site in Changzhou underwent a GMP monitoring inspection by the FDA, while the API site at Taixing completed a pre-approval (PAI) for the commercial production of a peptide-based therapeutic, without observation.
The enormous volume and the consistent success of these audits are compelling. In 2024, the company received 802 quality audits and inspections carried out by global customers, regulatory authorities and independent third parties, which again achieved a continuation rate of 100% without critical findings. This shows the robustness of the Quality Management System (QMS) under intense research, building enormous confidence among customers and supervisors.
Furthermore, Wuxi AppTEC (https://www.wuxiapptec.com/) Extends its quality spending to data security. 24 of the most important control sites, including all main sites in China, are ISO/IEC 27001 Information Security Management System certified. In 2024, the company successfully adopted 58 information security audits by global customers without critical findings.
So how ‘AppTEC AppTEC quickly’ replicates “his high -standard quality system about these new operational bases and facilities?
The remarkable capacity of WUXI AppTEC to quickly ‘replicate’ its high standard quality system in new facilities, is central to the global expansion. This capacity stems from an omnipresent company -wide quality culture, systematic training and robust quality control of the supply chain, which forms a synergistic ecosystem where quality is intrinsic from the first day.
Promote a penetrating quality culture
At Wuxi AppTEC, the quality is deep -rooted in the organizational DNA, from the laboratory bank to the boardroom. A strong quality culture means that quality is inherent in the approach of every employee.
Leadership involvement is of the utmost importance, whereby the Executive Board offers quality overview at top level and indicated it as a strategic imperative. This top-down emphasis creates an environment in which all employees are vigilant about quality. Quality is therefore seen as a accelerator, which makes faster, more reliable drug development possible, making participation in an all-member that ensures collective responsibility.
Systematic training and continuous competence development
To translate this quality culture into consistent implementation, Wuxi AppTEC implements an extensive, all year round through training plan. All staff members involved in product and service quality receive continuous education for quality management standards, process improvement, QMS training and specific R&D/production skills.
The Quality Assurance department (QA) is held responsible for conducting internal inspections, preparing customer audits and regulatory inspections and tackling findings through corrective and preventive measures.
Rigorous quality control of the Supply Chain
Quality extends over the entire value chain. Wuxi AppTEC has a robust assessment and qualification process for all suppliers, which means that the quality is built into the supply chain from the start. Important suppliers undergo regular audits to assess the quality of the product supply and long -term possibilities.
All incoming raw materials are subject to strict tests and certification, with continuous quality assurance. Wuxi AppTEC is committed to promoting mutually affordable collaborations with our suppliers to jointly improve the management of the quality of products and services.
Worldwide high -quality standard layout is an important strategy for Wuxi AppTEC to become a trusted partner for global customers. This is supported by a robust, globally harmonized QMS, a penetrating quality culture, systematic training, stringent supply chain checks and relentless dedication to intellectual property and data security.
In the competing CRDMO market, the consistent, globally recognized and independently controlled quality performance of Wuxi AppTEC is a powerful distinctive factor. This deep embedding of quality positions Wuxi AppTEC as a low risk, high-minded partner-a invaluable assets for pharmaceutical companies that navigate enormous regulatory control and responsibilities for patients’ safety.
Wuxi AppTEC
288 FUTE ZHONG ROAD WAIGAOQIAO Free Trade Zone, Pudong New Area, Shanghai, 200131, China
[email protected]
Wuxi AppTEC is a trusted partner and contributes to the pharmaceutical and life sciences industry, and offers O&O and production services that help promote healthcare innovation. With activities in Asia, Europe and North America we offer integrated, end-to-end services through our unique CRDMO platform (contract research, development and production organization).
This release is published on OpenPR.
