Recently, the Analytical Testing Center of Shanghai Medicilon Inc. (Medicilon) successfully passed the on-site assessment by the China National Accreditation Service for Conformity Assessment (CNAS). This marks that Medicilon's Analytical Testing Center has achieved international recognition standards for its testing results and service quality, laying a solid foundation for the company's continuous deepening in the biopharmaceutical R&D field and expansion into international markets in the future.
During this assessment, the CNAS expert team conducted a comprehensive and in-depth inspection of Medicilon's laboratory, covering several key aspects such as the quality manual, procedural documents, operational guidelines, on-site instruments and equipment, and experimental operations. Following a series of rigorous and professional review procedures, the expert team unanimously concluded that Medicilon's laboratory met the highest requirements of international standards, including ISO/IEC 17025:2017 "General Requirements for the Competence of Testing and Calibration Laboratories," in terms of its management system, technical capabilities, and operational standards.
The total area of Medicilon's Analytical Testing Center Laboratory exceeds 2,800 square meters. Its GMP system has successfully passed multiple on-site inspections by the NMPA. Currently, Medicilon's Analytical Testing Center has established platforms for various services, including genotoxicity research, physicochemical characterization research, microbiological research, impurity preparation and structure identification, trace impurity and residual solvent analysis, trace elemental impurity analysis, safety assessment tests, analytical method development, and quality control. These platforms can provide integrated drug analysis solutions and technical services to clients, encompassing routine physicochemical testing, specialized testing, chromatographic testing, and more. This supports new drug development, pharmaceutical CMC applications, and production release, aiding in the launch and internationalization of new drugs.
As an important member of the international laboratory mutual recognition system, CNAS accreditation signifies that Medicilon's Analytical Testing Center has established a quality management system that meets international standards and possesses the technical capabilities to perform calibration and testing according to the highest international standards. This accreditation not only serves as an authoritative recognition of Medicilon's technical strength and service quality but also bestows international authority and credibility on its test reports.
Under the wave of globalization, international collaboration in the field of biopharmaceutical research and development is becoming increasingly frequent. As a CNAS-accredited laboratory, Medicilon aims to seamlessly integrate into the international R&D network, sharing resources, exchanging experiences, and fostering collaborative innovation with global peers. This not only helps Medicilon showcase its technological strength and innovative achievements on the global stage but also injects new momentum into the internationalization of China's biopharmaceutical industry.
It's worth noting that Medicilon's CNAS on-site accreditation was not achieved overnight but stems from the company's years of relentless pursuit of technological innovation, rigorous quality management, and deep commitment to internationalization strategies. In 2023, Medicilon achieved several significant milestones, including obtaining GLP certification from the National Medical Products Administration for newly added experimental facilities and filing for ABSL-2 laboratory accreditation. At the same time, Medicilon actively absorbs international cutting-edge technology and advanced equipment, continuously upgrading and empowering its R&D "Arsenal."
Looking ahead, Medicilon will continue to uphold its service philosophy of 'innovation-driven, quality-focused’. With the CNAS on-site accreditation as a catalyst, Medicilon will further intensify investments and explorations in the biopharmaceutical R&D field, continuously enhancing the laboratory's technological capabilities and management standards. At the same time, Medicilon will actively participate in international exchanges and collaboration activities, advancing the internationalization of China's biopharmaceutical R&D service industry. Medicilon aims to contribute more Chinese wisdom and strength to the prosperity and progress of the global biopharmaceutical industry!
About CNAS
China National Accreditation Service for Conformity Assessment (CNAS) is the authoritative organization designated by the State Administration for Market Regulation of China, in accordance with the Regulations on Certification and Accreditation of the People's Republic of China and the Measures for the Supervision and Administration of Accreditation Institutions. CNAS is responsible for accrediting assessment activities of certification authorities, laboratories, inspection authorities, appraisal and verification authorities, and other conformity assessment authorities. It operates the national accreditation system for conformity assessment authorities in China.
CNAS is a full member of the International Accreditation Forum (IAF), the International Laboratory Accreditation Cooperation (ILAC), and the Asia-Pacific Accreditation Cooperation (APAC). Obtaining CNAS accreditation provides opportunities to participate in bilateral and multilateral collaboration and exchanges among internationally recognized conformity assessment authorities. Within its scope of accreditation, the testing reports issued by CNAS-accredited laboratories carry international credibility and authority.
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