Take the quality director as the core and take full charge of product quality management. Implement and implement the quality policy of "scientific management, continuous improvement", establish and implement drug quality management laws and regulations, and organize and standardize drug production quality management of the company. Establish and improve the drug quality management system, and monitor the whole process of the system to ensure its effective operation.
The quality management department is responsible for the daily quality management work and the implementation of various quality management functions. It covers the whole product life cycle, including product development, technology transfer, commercial production, product termination and other stages.
The pharmaceutical quality assurance department consists of inspection center, microbiological test center, physical and chemical center, workshop central control room and other functional clear organizations. It has many advanced instruments and equipment, such as water, semefei, Shimadzu, atomic absorption spectrometer, gas chromatograph, ion chromatograph, infrared spectrometer, automatic intelligent dissolution system, aseptic isolation system, real-time monitoring system for microbial culture, etc.
The drug quality control management and training system is sound, with a team of more than 80 people with high education background, strict training in self-discipline and rich experience in drug assurance and control management, 90% of them are national licensed pharmacists, 70% of them are middle and senior technical personnel, with an average age of 30, young and energetic, active in thinking, serious and willing to accept new things and challenges.
It is our biggest responsibility to ensure that the drug quality risk is controllable. Inspire and motivate employees with the mission of "creating smile with heart". The quality mission is always remembered and the risk is under my control. Have a deep understanding of what you are doing and how you are doing it. From the inside out, the "4 + 1" quality risk management and control mode has been established, namely four first-class (first-class talents, first-class management, first-class service, first-class performance) and continuous improvement. The high standard dynamic management of drug quality risk should be carried out according to the four strictest requirements.
Through scientific and reasonable personnel quota and objective management, the system of post quality supervisor is implemented, and the self inspection function of team post is brought into play to guarantee the quality of drugs.