Today, CrystalFormulation Services (CFS) successfully obtained certifications in both GoodManufacturing Practices (GMP) and Good Distribution Practices (GDP) from SGS,an internationally recognized third-party certification agency, in line withthe World Health Organization (WHO) standards. This significant milestonesignifies that CFS has met the requirement of international authoritativecertification standards in various aspects such as technical capabilities,quality management systems, compliance, and facility construction.
During the certification inspection, SGS inspectors performed a comprehensive one-week on-site inspectionat CFS in Suzhou. Through various aspects, such as company presentations, facilitytours, document reviews, personnel interviews, and inspection of productionactivities, SGS did holistic review of the CFS's quality management system,factory facilities, equipment, and workforce expertise. Based on the overall observations,the auditors accorded complete recognition and endorsement on GMP & GDPcompliance.
As a leading global third-party independent audit andcertification organization, SGS issues compliance certificates based on WHOGMP/GDP guidelines, which are internationally recognized guiding principlesthat serve as key standards for the global pharmaceutical industry . Thiscertification signifies that CFS’ quality systems and facilities align withinternationally accepted good manufacturing and distribution practices forpharmaceuticals, providing reliable quality assurance for our services in localand multi-regional clinical trials. Itwill help ensure that our services consistently meet high-quality standards andfulfill global customer expectations.
CFS' Clinical Supply Center offers end-to-end clinicalsupply services, covering all supply services in the research and developmentstages, including pre-clinical, clinical phases I-III, and post-market studies.Our center can also support commercial supply chain for finished drug products.With ICH-compliant storage capabilities in temperature zones ranging from15°C-25°C, 2°C-8°C, -15°C- -25oC as well as an electronic material managementsystem, we provide services such as primary and secondary packaging, storageand distribution, import and export, return and destruction, comparatorsourcing, and ancillary supplies. Equipped with a professional projectmanagement and operation team of over a decade of industry experience, CFS providessecured professional, accurate, compliant, and efficient clinical supplyservices.
Additionally, as a specialized oral dosage form CDMO, CFShas established a quality management system that complies with GMP standards inChina, the United States, and Europe, holding the NMPA (National MedicalProducts Administration) drug production license and having successfully passedcompliance audits from numerous of domestic and international innovativepharmaceutical companies. We adhere to core values of technical excellence andintegrity, committed to providing global clients with high-quality formulationdevelopment and manufacturing services.
Dr. Decheng Ma, CEO of Crystal Formulation Services, stated:"We are very grateful to SGS experts for their inspection and feedback onCFS’s quality management system and our facilities. CFS has been committed toserving global pharmaceutical clients with high standards of quality andefficiency. The GMP&GDP certificates from SGS hasprovided a prestigiousendorsement for our clinical supply business. We will continue to improve andexpand our capabilities and look forward to the success of our clinical supplyoperations!”
Dr. Alex M. Chen, Chairman and CEO of Crystal Pharmatech,remarked, "The successful attainment of GMP/GDP certification demonstratesthe compliance of Crystal Formulation Services' quality management system andfacility construction. It further strengthens the trust relationship we havewith our partners and customers. In the future, Crystal Formulation Serviceswill continue to enhance our internal quality management system, refine ourcrystalline and formulation capabilities, and ensure that our research anddevelopment, production, and clinical supply services consistently adhere tohigh-quality standards. By starting with the end in mind, we are dedicated tocontinually supporting the steady and rapid development of our pharmaceuticalclients."