Testing and Certification Center is a third-party service technology platform that provides one-stop drug quality research and release testing. It is located at Building #10, Qingdao International Academician Park Industrial Core Experimental Zone, with a total area of more than 4,000 square meters and more than 90 sets of large analytical instruments as well as a team of more than 30 professional personnels.
Testing and Certification Center establishes a comprehensive quality management system in accordance with the requirements of cGMP and CNAS regulations, and provides customers with drug release and testing services, drug quality research services, genotoxic impurities research services, elemental impurities research services, impurity identification research services, process safety assessment services and so on, which completely meets the global regulatory requirements.
Adhering to the service tenet of "fair and scientific, accurate and standardized, high-quality and efficient, and sustainable development", Testing and Certification Center continuously strengthens the construction of the system and the building of qualified and competent personnels, and provides customers with high-quality and efficient drug testing and R&D analysis services with a compliant quality system and a professional technical team.
Testing and certification center has China Inspection Body and Laboratory Mandatory Approval (CMA) and is accredited by the China National Accreditation Commission for Conformity Assessment (CNAS) laboratory. And on the basis of the good ISO17025 system, strictly refer to the cGMP standard operation, adhering to the values of fairness of science, accurate standardization, high-quality and efficiency, and sustainable development for customer services.
With professional technical team, to provide the best quality analysis and testing services;
With top equipment to meet the different demands of research and development and production;
With compliance quality system to ensure the authenticity, reliability and integrity of data;
With lean project management, report customer project progress anytime and anywhere;
With multi-dimensional training methods, to create a high level, high quality analytical personnels.
The testing and certification center is well-equipped with advanced analytical equipment such as Fourier transform NMR, high resolution mass spectrometry, powder diffractive analyzer and reaction calorimeter, which can meet the customer’s special requirement. The instruments and equipment have passed the IQ/OQ/PQ verification and are equipped with the network version of the chromatographic data acquisition system, and the detection data can be used for the report of NMPA, IND, NDA, ANDA and any other drugs.
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