Today, Crystal Formulation Services (CFS) successfullypassed a remote audit conducted by a US client. The audit, which lasted forfour days, demonstrated that CFS's infrastructure, quality systems, verificationand validation procedures are in compliance with international cGMP standards,laying a solid foundation for the company to provide CDMO services that meetsthe regulations of the the FDA, NMPA, and EMA.
The audit was focused to confirm that the GMP manufacturingfacility of CFS meets the US GMP regulations, and to ensure that the compliancein manufacturing and testing of drugs to be used in clinical trials in the USA.The scope of this audit included quality management systems (QMS), material andsample management, facilities and equipment, pollution and cross-contaminationprevention and control, deviation/OOS investigation, change control, suppliermanagement, training, confirmation and validation, data integrity and riskassessment, etc.
During the audit process, the experienced auditorsthoroughly evaluated CFS's quality systems, GMP facilities, manufacturing andpackaging facilities, warehouse, processes, and documentation system throughreviewing the various documents, online real-time meetings, virtual facilitytours, Q&A sessions with staff, technical discussions, etc. Thecomprehensive, accurate and timely manner of CFS showcased that itshigh-standard equipment and QC facilities met the customer's expectations inall aspects. After the completion of the remote audit, the auditors providedpositive feedback.
"This successful remote audit is a key milestone forCFS, as we continue to expand our high-quality CDMO services globally,"said Dr. Decheng Ma, CEO of Crystal Formulation Services, "It demonstratesthat the GMP system we have built over the past year has gained recognitionfrom our international clients. We will continue to work hard to furtherenhance our company's quality management level and lay a solid foundation forCFS' future, and fulfill our mission of providing high-quality oral formulationdevelopment and manufacturing services for global clients, accelerating theirmarket launch, and enabling patients to use high-quality drugs as soon aspossible."
Dr. Alex Chen, Chairman and CEO of Crystal Pharmatech, said,"This successful remote audit by our US client marks that CrystalPharmatech is capable of producing and delivering products and clinical trialsamples that comply with US GMP regulations. Crystal Pharmatech and itssubsidiary Crystal Formulation Services will continue to embrace our culturalvalues of Perfection and Exceeding, focusing on customer demands, and relyingon a complete quality system to provide customers with the optimal API form andformulation. We will work together with our clients to help develop and launchmore innovative and effective drugs in the coming future.”