SUZHOU, China, Dec. 4, 2023 /PRNewswire/ -- Recently, Crystal Pharmatech's CDMO Business Unit - Crystal Formulation Services (CFS) successfully obtained dual certification in Good Manufacturing Practices (GMP)[1] and Good Distribution Practices (GDP)[2] from SGS, an internationally recognized third-party certification agency, in line with the World Health Organization (WHO) standards. This significant milestone signifies that CFS has met the requirement of international authoritative certification standards in various aspects such as technical capabilities, quality management systems, compliance, and facility construction.
During the certification inspection, SGS dispatched experienced certification inspectors for a comprehensive one-week on-site evaluation of CFS. Through various methods such as company presentations, document reviews, personnel interviews, and dynamic inspection of production activities, SGS meticulously scrutinized CFS's quality management system, factory facilities, equipment, and workforce expertise. Based on the comprehensive observations, the inspection team accorded complete recognition and endorsement.
WHO GMP/GDP is a comprehensive and internationally recognized set of guiding principles that serve as key standards for the global pharmaceutical industry. As a leading global third-party independent audit and certification organization, SGS issues compliance certificates based on WHO GMP/GDP guidelines, which are widely acknowledged and esteemed within the industry. This 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. It will help ensure that our services consistently meet high-quality standards and fulfill customer expectations.
CFS's Clinical Supply Center offers end-to-end one-stop clinical supply services, covering all supply services in the research and development stages, including pre-clinical, clinical phases I-III, and post-market studies. With GMP-compliant storage capabilities in temperature zones ranging from 15°C-25°C, 2°C-8°C, -20°C and deep freezing, as well as an electronic management system, we provide services such as primary and secondary packaging, storage and distribution, import and export, recycling and disposal, procurement of comparator drugs and ancillary materials. With a professional project management and operation team with over a decade of industry experience, CFS ensures professional, accurate, compliant, and efficient clinical supply services.
Additionally, as a specialized oral dosage form CDMO, Crystal Formulation Services has established a quality management system that complies with GMP standards in China, the United States, and Europe, holding the NMPA (National Medical Products Administration) drug production license and having successfully passed compliance audits from numerous of domestic and international innovative pharmaceutical companies. We adhere to core values of technical expertise and integrity, committed to providing customers with high-quality formulation development and manufacturing services.
Dr. Decheng Ma, CEO of Crystal Formulation Services, stated: "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. We also appreciate the efforts of our team members and the authoritative certification from SGS, which has provided a prestigious endorsement for our clinical supply business. We will continue to accelerate and look forward to the soaring success of our clinical supply operations!"
Dr. Alex M. Chen, Chairman and CEO of Crystal Pharmatech, remarked, "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. In the future, Crystal Formulation Services will continue to enhance our internal quality management system, refine our crystalline and formulation capabilities, and ensure that our research and development, production, and clinical supply services consistently adhere to high-quality standards. By starting with the end in mind, we are dedicated to continually supporting the steady and rapid development of our pharmaceutical clients."
To know more, please visit https://www.crystalpharmatech.com or contact us via bd_global@crystalpharmatech.com.
[1] GMP Certificate: Crystal Formulation Services can provide primary packaging services for clinical drugs under temperature conditions of 15-25°C (such as blister packs, bottles, bubble wraps); also provides secondary packaging services for different temperature conditions of 15-25°C, 2-8°C, and -25 to -15°C (such as blister cards, cartons, and corresponding labeling operations). |
[2] GDP Certificate: Crystal Formulation Services can provide storage (receiving and storing) and transportation (shipping and retrieval) services for clinical drugs under different temperature conditions of 15-25°C, 2-8°C, and -25 to -15°C. |
