Crystal Pharmatech's CDMO Business Unit, Crystal Formulation Services (CFS), achieved dual certification in Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) from SGS, a globally recognized third-party certification agency following World Health Organization (WHO) standards. This milestone confirms CFS's adherence to international certification standards in technical capabilities, quality management systems, compliance, and facility construction.
SGS conducted a thorough one-week on-site evaluation using various methods, including presentations, document reviews, interviews, and dynamic inspections. The inspection team fully recognized and endorsed CFS based on comprehensive observations.
The WHO GMP/GDP certification, widely acknowledged in the pharmaceutical industry, signifies alignment with globally accepted standards for manufacturing and distributing pharmaceuticals. CFS's certification assures reliable quality assurance for services in local and international multi-center clinical trials, ensuring consistent adherence to high-quality standards and meeting customer expectations.
CFS's Clinical Supply Center provides end-to-end clinical supply services for research and development stages, with GMP-compliant storage capabilities in various temperature zones. Services include packaging, storage, distribution, import/export, recycling, disposal, and procurement of comparator drugs and ancillary materials. With a professional project management team, CFS guarantees professional, accurate, compliant, and efficient clinical supply services.
As a specialized oral dosage form CDMO, Crystal Formulation Services complies with GMP standards in China, the United States, and Europe, holding the NMPA drug production license. Upholding core values of technical expertise and integrity, CFS is committed to delivering high-quality formulation development and manufacturing services to its customers.
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