WuXi Biologics Achieves GMP Certification for Quality Assurance
WuXi Biologics Earns GMP Certification for Facilities
WuXi Biologics, a prominent player in the Contract Research, Development, and Manufacturing Organization (CRDMO) sector, proudly shared news of its recent achievement: the successful GMP certification of three of its cutting-edge manufacturing facilities. This certification, awarded by Türkiye ?laç ve T?bbi Cihaz Kurumu (TITCK), marks a significant milestone in the company's ongoing commitment to maintaining rigorous quality standards across its extensive operational network.
Significance of the Certification
The three facilities, known as MFG1, MFG2, and DP5, recently underwent an in-depth inspection that lasted five days. This inspection focused on two monoclonal antibody biologics that WuXi Biologics produces for its global clientele. The successful passing of the TITCK's rigorous assessment not only validates the company’s high-quality service offerings but also underscores its dedication to meeting international standards.
Commitment to Global Standards
WuXi Biologics has established a remarkable history of adherence to the highest quality benchmarks in the biopharmaceutical landscape. The company has successfully navigated 44 regulatory inspections, with a notable number conducted by recognized authorities, including the FDA and EMA. Impressively, it boasts a 100% pass rate for Pre-License Inspections by the FDA, reflecting its outstanding commitment to quality.
Enhancing Client Trust
The company also has a proven track record of passing over 1,700 GMP audits from global clients, with more than 200 of those audits performed by EU Qualified Persons. Currently, WuXi Biologics operates 16 GMP-certified facilities devoted to drug substance and drug product manufacturing worldwide. Such achievements solidify their reputation as a trusted partner in the biopharmaceutical field.
Leadership Insight
Dr. Chris Chen, CEO of WuXi Biologics, expressed his excitement regarding the GMP certification from Turkey's TITCK. He described it as a key recognition in the Turkish market, emphasizing WuXi Biologics' capability to penetrate emerging markets effectively. Dr. Chen stated, "Understanding that quality is essential for safety and efficacy in the pharmaceutical sector drives our commitment to uphold the highest standards available in the market. We remain focused on continually enhancing our quality systems and service capabilities."
About WuXi Biologics
As a leader in the CRDMO space, WuXi Biologics (stock code: 2269.HK) provides end-to-end solutions that empower partners to innovate, develop, and manufacture biologics that greatly benefit patients around the globe. The company has a diverse workforce of over 12,000 skilled professionals located in various countries, leveraging cutting-edge technologies to offer practical and economical solutions for biologics discovery and development.
Commitment to Sustainability
WuXi Biologics stands firm in its belief that sustainability is crucial for long-term success. The company actively advocates for green technologies while delivering environmentally sustainable CRDMO solutions. This commitment extends to ensuring that every stakeholder involved benefits from responsible practices that create both social and environmental value.
Frequently Asked Questions
What does GMP certification mean for WuXi Biologics?
The GMP certification signifies that WuXi Biologics’ facilities meet international quality standards for manufacturing biologics, ensuring product safety and effectiveness.
Why is the TITCK certification significant?
This certification is a key endorsement from Turkey, opening new market opportunities for WuXi Biologics and reflecting their commitment to global quality standards.
How many facilities of WuXi Biologics are GMP certified?
Currently, WuXi Biologics operates 16 facilities that are GMP-certified, reassuring clients of their commitment to high-quality manufacturing.
What is the role of Dr. Chris Chen in the company?
Dr. Chris Chen is the CEO of WuXi Biologics and plays a crucial role in leading the company's strategic initiatives and quality programs.
How does WuXi Biologics ensure sustainability?
WuXi Biologics drives sustainability through innovative green technologies and responsible practices that promote environmental and social value creation.
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