Crystal Formulations Services (CFS) has achieved a significant milestone bysuccessfully passing the on-site GMP audit by the European Qualified Person (QP).
This achievement represents another landmark for CFS' global standard qualitymanagement system, coming on the heels of acquiring the NMPA pharmaceuticalproduction license and successfully passing the SGS GMP/GDP inspection. Itsignifies that the CFS' formulation manufacturing facility and qualitymanagement system fully meet the EU cGMP requirements, laying a solidfoundation for the company's global CDMO service layout.
The audit was led by an EU QP expert who has nearly 40 yearsof experience in the pharmaceutical industry, including over 20 years on the EUQP roles and extensive cGMP verification expertise. The entire inspection wasbased on the EudraLex Vol 4 (also known as EU GMP) regulations, covering CFS'sformulation production and clinical supply operations. The auditor comprehensivelyassessed the company's facilities, quality management system, personnelknowledge and skills, and on-site operations.
The CFS team's fluency in English also played an importantrole in ensuring the auditor’s clear understanding of our international qualitymanagement system and smooth communication with the questions. The auditorhighly recognized CFS' facilities, world-class production and inspectionequipment, quality management system, and experienced staff, referring to it asa "High-Level Quality System."
Dr. Decheng Ma, CEO of CFS, stated: "Successful passingof this EU QP audit demonstrated CFS' commitment to exemplary quality systemsand compliant production processes. It also shows that CFS has taken a new stepin its international strategic layout! Achieving this result would not havebeen possible without the effort and dedication of every employees. We willcontinue to improve our quality management systems and, fulfill our mission of'providing high-level oral formulation R&D, production, and clinical supplyservices for global new drug clients, and accelerating the development ofinnovative drugs.'"
Dr. Alex M. Chen, Chairman and CEO of Crystal Pharmatech,expressed: " Achieving this EU QP audit milestone is crucial for our EUfilings, demonstrating unequivocally CFS's capability to produce and deliverproducts adhering to EU GMP standards. Crystal Pharmatech and CrystalFormulation Services will continue to strengthen their quality managementsystem standards, always adhere to the core philosophy of 'pursuingtechnological innovation, creating exceptional quality, and establishing aleading advantage'. With greater efficiency and higher standards, they willtailor 'First-Time-Right' crystallization and formulation strategies for globalinnovative drug clients, empower partners, and accelerate the entry ofinnovative drugs in the market."