Crystal Pharmatech's CDMO Division, Crystal Sky Pharma, Successfully Passes EU QP Audit
Recently, the CDMO division of CRYSTAL Pharmatech—Suzhou Crystal Star Pharmaceutical Co., Ltd. (hereinafter referred to as “Crystal Star”)—successfully passed the on-site audit conducted by a European Qualified Person (QP) on its GMP quality system and manufacturing facilities.
The successful completion of this EU QP audit marks another milestone achievement for CRYSTAL Pharmatech’s quality management system, following its acquisition of the NMPA Drug Manufacturing License and its successful passage of the SGS GMP/GDP audit certification, signifyingCRYSTAL Pharmatech’s formulation R&D and production base, along with its quality management system, fully comply with EU cGMP requirements., laying a solid foundation for the company's advancement of its global commercialization strategy.
CRYSTAL Pharmatech Team Members Pose for a Group Photo with EU QP Auditors
The Lead Auditor for this EU QP audit possesses nearly 40 years of experience in the pharmaceutical industry, including over 20 years as an EU Qualified Person (QP) and extensive experience in cGMP inspections. The entire audit process was conducted in accordance with EudraLex Volume 4 (commonly referred to within the industry as EU GMP) regulations. It covered CRYSTAL Pharmatech’s drug product manufacturing and clinical supply operations, providing a comprehensive assessment of the company’s facilities, equipment, quality management system, personnel knowledge and skills, and on-site operational practices.
The CRYSTAL Pharmatech team’s strong proficiency in English enabled the auditor to gain a comprehensive understanding of the company’s establishment and operation of an internationalized quality management system. The auditor highly recognized and praised CRYSTAL Pharmatech for its excellent facility infrastructure, world-class production and testing equipment, high-level quality management system, and experienced staff:“High Level Quality System”。
Dr. Ma Decheng, CEO of CRYSTAL Pharmatech, stated, “The successful completion of this EU QP audit is a testament to CRYSTAL Pharmatech’s robust quality system and compliant manufacturing practices, marking a significant milestone in our international strategic layout. This achievement would not have been possible without the dedication and hard work of every project team member. We will continue to advance steadily, further strengthening our quality management systems to better fulfill our mission of providing high-level R&D, manufacturing, and clinical supply services for oral formulations to global new drug clients, thereby accelerating innovative drug development.”
Dr. Chen Minhua, Chairman and CEO of CRYSTAL Pharmatech, stated, “Passing the EU Qualified Person (QP) audit is a critical milestone for EU regulatory filings, demonstrating that Crystal Sky possesses full capability to manufacture and deliver products in compliance with EU GMP regulations. CRYSTAL Pharmatech and Crystal Sky will continue to strengthen their quality management system standards, adhering to the core philosophy of ‘pursuing technological innovation, delivering exceptional quality, and establishing a leading advantage.’ We are committed to providing global innovative drug clients with customized, ‘right-first-time’ crystal form and formulation strategies with greater efficiency and higher standards, empowering our partners to accelerate the market launch of innovative drugs and make more significant contributions to human health.”