Quality Assurance(QA)

     QA is to be focused on insurance of the project quality in each stage, we establish and maintain ISO9001 quality management system, to ensure the system effective operation and continuous improvement, including management of quality system, measurement and validation of instruments, environmental monitoring, audit of the registered declaration data, outsourcing company audit, production site supervision and on-site verification for drug registration . QA department aims to ensure that the research and development (R&D) of the innovative drugs comply with national regulations in quality and safety. In accordance with GMP/GLP principles, QA provides service and monitors the R&D of various projects to make sure the projects are completed in a orderly, efficient and standardized way. Finally,we ensure that the R&D content is true, complete and scientific.

Data Information Management System & Database

  XuanZhu Pharma has a custom-designed data information management system and several databases. All data from preclinical and clinical research are submitted to the database for unified management, so as to ensure the safety and standardability of the information, what’s more, it becomes easier to retrieve original data and make analysis and comparison for innovative drug R&D in all respects; besides, a set of complete service management system is also built to support material requisition and search functions. This database provides adequate R&D data and material security support for the projects of the company.


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