In order to further strengthen quality and safety management in terms of key time period, key links and key varieties to ensure the drug safety for the masses, a summary on Spring Breeze Action for Drug Safety in Hefei region and the quality supervision work of drugs used for the prevention and treatment of key infectious diseases and regulation publicity meeting was organized by the first branch of Anhui Medical Products Administration and held in Huayi Pharmaceuticals (Anhui) Co., Ltd. on April 3. A total of 42 people including Head of enterprise, Head of Quality etc. key personnel of 22 enterprises attended the meeting.
At the meeting, representatives of 4 enterprises made exchange speeches, focusing on the construction of drug quality and safety risk investigation mechanism, quality assurance of contract manufacture varieties and collectively procured varieties, improvement of pharmacovigilance capacity, optimization of quality management system, change control, etc., and shared their specific cases explaining the effectiveness and experience in the quality management of drug manufacture, which provided references for the attendees. Subsequently, the branch reported the overall situation of the 2024 Spring Breeze Action for Drug Safety and the quality supervision of drugs used for the prevention and treatment of key infectious diseases in winter and spring, analyzed the risk points of the enterprises in the drug production process based on the deficiencies found in the inspection, and interpreted the law with the cases to warn the enterprises to strengthen the awareness of compliance and to ensure that the drug’s safety, efficacy and accessibility.
The meeting emphasized that, firstly, we should focus on the quality and safety management of drugs used for the prevention and treatment of key infectious diseases, strengthen the control of the production process of the relevant drugs and the study of changes and resumption of production, and ensure that the drugs are stable in price and quality. Secondly, we should focus on risk investigation and disposal, continue to improve the quarterly analysis, research and judgment mechanism, coordinate personnel and resources, regularly investigate and dispose of risks, do a good job of self-inspection and self-correction, and eliminate hidden safety hazards in a timely manner. Thirdly, we should focus on correction of deficiencies, improve the enterprise closed-loop management mechanism for deficiencies and correction, draw inferences about other cases from one instance to ensure that the cause is deeply analyzed and the corrective and preventive measures are sufficient, and continuously improve the quality management level of enterprises. Fourthly, we should focus on quality improvement, summarize the effectiveness and experience of the quality improvement work in 2023, adhere to the problem-oriented principle, and further plan the quality improvement in 2024 so as to promote the benign interaction between the enterprise’s high-quality development and high-level safety.
Through this meeting, it not only provides a valuable experience exchange platform for Huayi’s drug safety supervision work, but also injects new vitality into the healthy development of drug industry. In the future, with the continuous improvement of regulations and regulatory technology, Huayi’s drug safety will also be more scientific and efficient, providing a solid guarantee to ensure public drug safety.