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Crystal Pharmatech’s CDMO Unit Obtains GMP/GDP Certification

Meets requirements in technical capabilities, quality management systems, compliance, and facility construction.

Crystal Pharmatech’s CDMO business unit, Crystal Formulation Services (CFS), has obtained dual certification in good manufacturing practices (GMP) and good distribution practices (GDP) from SGS, an internationally recognized third-party certification agency, in line with the World Health Organization (WHO) standards. 

CFS has met the requirement of international authoritative certification standards in various aspects such as technical capabilities, quality management systems, compliance, and facility construction.

Through various methods such as company presentations, document reviews, personnel interviews, and inspection of production activities, SGS reviewed CFS’s quality management system, factory facilities, equipment, and workforce expertise. Based on the comprehensive observations, the inspection team accorded complete recognition and endorsement.

The certification signifies that CFS’s systems and facilities align with internationally accepted good manufacturing and distribution practices for pharmaceuticals, providing reliable quality assurance for our services in local and international multi-center clinical trials.

Decheng Ma, CEO of Crystal Formulation Services, said, “We are very grateful to SGS experts for their guidance on CFS’s quality management system and the professional and rigorous inspection, which has garnered high recognition for CFS. CFS has always been committed to serving global pharmaceutical clients with high standards of quality and efficiency.”

Alex Chen, Chairman and CEO of Crystal Pharmatech, said, “The successful attainment of GMP/GDP certification demonstrates the compliance of Crystal Formulation Services’ quality management system and facility construction. It further strengthens the trust relationship we have with our partners and customers.”
 
 

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