We has a complete management system, through the project team management system to manage the project; through the R&D quality management system, to ensure the standardization and compliance in the R&D process; through generic drug R&D and technology transfer and other related systems, to manage the content of research and technology transfer needs to be handed over.
Project team management system, the implementation of the project leader system. Project managers organize project team members to complete project development reports, formulate project development plans and corresponding timelines, and strictly implement them. During the R&D process, project team members regularly report and summarize the progress and send it to relevant personnel. Project managers regularly organize project meetings, follow up the R&D process of the project, coordinate departments to solve the problems in R&D, and regularly report project progress to customers, actively communicate with customers, to ensure that customers understand the process of project research.
The R&D process of conformity evaluation of generic drugs stipulates the responsibilities of each department in the R&D process and the basic requirements of each stage in the R&D process. The relevant documents should be formed in each stage of R&D to ensure the integrity of R&D data. The management rules of technology transfer are formulated, and the basic process of technology transfer is stipulated, as well as the relevant information that needs to be provided to customers. Ensure that technology transfer can proceed smoothly.
The company has a clear quality policy, according to GMP management requirements, formulated relevant standard operating procedures, standardize the management requirements of R&D process. GMP links in R&D are controlled from personnel, equipment, materials, records, reference materials, analysis methods, quality standards, suppliers and other aspects to ensure data integrity, accuracy and traceability. The relevant regulations of the quality management system have been formulated to ensure the effective operation and continuous improvement of the quality system. A management review system has been established to ensure that management can understand the operation of the company's quality system. Personnel, new recruits and on-the-job personnel each year to develop appropriate training plans to ensure that qualified personnel to carry out appropriate operations. In terms of equipment management, there are clear management rules, which specify the relevant management requirements for equipment, such as the need for equipment verification; equipment confirmation should be completed before the first use, and regular performance confirmation should be carried out. The experimenter records the test process in detail to ensure the traceability of the experimental data.