SUZHOU, China, Jan. 31, 2024 /PRNewswire/ — Recently, Crystal Formulations Services (CFS), the CDMO Business Unit of Crystal Pharmatech has achieved a significant milestone by successfully passing the on-site audit conducted by the European Qualified Person (QP), evaluating its GMP quality system and production facilities.
This achievement represents yet another landmark for CFS’s robust quality management system, coming on the heels of acquiring the NMPA pharmaceutical production license and successfully clearing the SGS GMP/GDP audit certification. It signifies that CFS’s formulation R&D and production base, and its quality management system, fully meet the EU cGMP requirements, laying a solid foundation for the company’s global commercialization layout.
The audit was led by an expert EU QP auditor who has nearly 40 years of experience in the pharmaceutical industry, including over 20 years in EU QP roles and extensive cGMP verification expertise. The entire process referenced EudraLex Vol 4 (also known as EU GMP) regulations, covering CFS’s formulation production and clinical supply operations. It comprehensively assessed the company’s facilities, quality management system, personnel knowledge and skills, and on-site operations.
The CFS team’s fluency in English played a crucial role in ensuring the auditor’s grasp of the intricacies of the company’s international quality management system and its operational excellence. The auditor highly recognized and praised CFS’s facilities, world-class production and inspection equipment, high-level quality management system, and experienced staff, referring to it as a "High-Level Quality System".
Dr. Decheng Ma, CEO of CFS, stated: "Successful passing of this EU QP audit underscores CFS’s commitment to exemplary quality systems and compliant production processes, and also means that CFS has taken a new step in its international strategic layout! Achieving this result would not have been possible without the effort and dedication of every project member. We will continue further solidify our quality system management level, and better fulfill our mission of ‘providing high-level oral formulation R&D, production, and clinical supply services for global new drug clients, and accelerating the development of innovative drugs.’"
Dr. Alex M. Chen, Chairman and CEO of Crystal Pharmatech, expressed: "Achieving this EU QP audit milestone is crucial for our EU filings, demonstrating unequivocally CFS’s capability to produce and deliver products adhering to EU GMP standards. Crystal Pharmatech and Crystal Formulation Services will continue to strengthen their quality management system standards, always adhere to the core philosophy of ‘pursuing technological innovation, creating exceptional quality, and establishing a leading advantage’. With greater efficiency and higher standards, they will tailor ‘First-Time-Right’ crystallization and formulation strategies for global innovative drug clients, empower partners, and accelerate the entry of innovative drugs in the market."
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