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QA

Our quality system is composed of our Quality Control Department and Quality Assurance Department. They ensure compliance to GMP standards with quality management systems encompassing activities such as documentation, quality control, validation (plant, equipment and computer system), audit and regulatory document submissions.

ISO9001:2000 standard was strictly complied while the concept of current Good Manufacturing Process (cGMP) has been carried out for all the process from raw material procurement, production control, quality analysis to products release and after-service. Standard Operation Procedures (SOPs) are established throughout each production process. From raw materials purchasing and production through product distribution. Complete SOP files were established by the QA department and are performed strictly in the entire factory.

QC

The quality of our products is under strict supervision and control within TIANMA Group. In our plant, we have an independent Quality Control Lab testing the final products, which has a whole set of instruments including Chromatography, Spectrometer, Titration and more. On the basis of physical and chemical characteristics, product application and synthesis routes, a proper quality standard system, test and analysis methods and quality control criteria are established for each production process. The Quality Control Laboratory follows the GMP operating systems based on ICH Q7A.

Our instruments include: