On November 5th, the sixth Taizhou Pharmaceutical Quality Research Salon, hosted by Taizhou Pharmaceutical Association and Pharmaceutical Quality Research Professional Committee and undertaken by Wanbangde Pharmaceutical Group Co., Ltd., was successfully held in Wenling International Hotel. The purpose of the event is to further exert the power of industry organizations, build a communication platform, share quality management experience and achievements, and inject vitality into the high-quality development of pharmaceutical enterprises in our city. This session of the salon conducts exchanges and discussions on the theme of "OOS Survey".

Li Xiongwei, Director of Taizhou Market Supervision Administration, Wang Huiqun, Deputy Director, Zeng Maofa, President of Taizhou Food and Drug Inspection and Research Institute, Wang Ping, Deputy Director of Taizhou Drug Certification and Inspection Center, and representatives of market supervision and administration bureaus in other districts and counties in Taizhou More than 80 people, including Lin Hong, Deputy General Manager of Quality of Wanbangde Pharmaceutical, Hu Shiqin, Deputy General Manager of Administration, and representatives of ten companies that are members of the Professional Committee of Pharmaceutical Quality Research of Taizhou Pharmaceutical Association, participated in this salon.

First of all, Deputy General Manager Lin Hong extended a warm welcome and heartfelt thanks to the leaders and guests who came to the conference during their busy schedules. She said that the establishment of the "Drug Quality Research Salon" platform by the Taizhou Pharmaceutical Association is of great significance to promoting the improvement of the city's pharmaceutical production quality management level. Through on-site academic exchanges, different ideas collide to spark, quickly reach consensus, and gain more inspiration and benefits. Wanbond Pharmaceutical attached great importance to this salon event, made careful arrangements and careful planning, and made full preparations. Then she introduced the six agendas of this salon, including company visits, keynote speeches, introduction of participating companies, group discussions, consensus suggestions, and leadership speeches. Finally, she sincerely wished this salon a complete success.

Afterwards, Li Xiongwei, Director of Taizhou Market Supervision Administration, and more than 80 guests, led by Lin Hong, Deputy General Manager of Quality of Wanbangde Pharmaceutical, and Hu Shiqin, Deputy General Manager of Administration, divided into two groups to visit Wanbangde Pharmaceutical Ginkgo Biloba. Dropping pill workshop fully automatic packaging production line and company showroom. The instructor introduced the company's development history, industrial layout, advantageous products and advanced technology in detail. The guests at the meeting experienced the charm of Wanbangde Pharmaceutical's intelligent manufacturing, and were amazed at the efficient automation equipment and advanced production technology.

Then Zhao Shouhu, QC Director of Wanbond Pharmaceutical, gave a keynote speech titled "OOS Investigation". He elaborated on the history of OOS, the OOS investigation process based on MHRA (UK Medicines and Health Products Regulatory Agency), and the OOS in practical work. Prevention, detailed analysis of the process difference between FDA (US Food and Drug Administration) and MHRA in OOS investigation, detailed description of some common cases in OOS investigation, and shared the process and experience of Wanbond Pharmaceutical in OOS investigation. Representatives of various enterprises also introduced the OOS/OOT investigation of their enterprises in turn, and put forward the common problems encountered by their enterprises during the inspection process, and hoped to be able to solve their doubts in the following group discussions.

At the group discussion meeting, the participants of each enterprise were divided into six groups to discuss 21 representative questions about OOS investigation principles and procedures, laboratory investigation, and deviation handling submitted by representatives of various enterprises in the previous stage. During the discussion, the representatives of each enterprise put forward their own practices, and at the same time, they also raised their own questions and opinions. By basically reaching a consensus in the discussion group on the above-mentioned issues, after the discussion, each group will send representatives to state the results of the discussion, and have a heated debate with other groups, and finally reach a consensus. Through this exchange, preliminary solutions were obtained to the 21 common problems submitted by the participating companies. The participants further unified their understanding and investigation process of OOS investigation in their daily work, which improved the level of investigators and enriched their professional knowledge. It has profound guiding significance for enterprises to improve the OOS investigation process and the comprehensiveness and integrity of the investigation work.

Then, leaders of government departments and representatives of industry experts made concluding speeches, mainly focusing on the common problems and challenges in the theme of the salon, and expressed their opinions and suggestions. Wang Huiqun, deputy director of the Taizhou Municipal Market Supervision and Administration Bureau, said that all professionals should have a rigorous attitude and the spirit of nailing the nails, formulate correct operation plans based on the principle of risk management, and do a good job of prevention is the goal. The successful holding of this salon event has benefited a lot. The common problems in the drug production process were solved through group discussions, and a consensus was reached, which is conducive to further implementing the goals of drug safety production and quality and safety supervision. Wang Ping, deputy director of the Taizhou Drug Certification and Inspection Center, pointed out that the OOS investigation must firstly start the investigation in accordance with the laws and regulations, secondly carry out the investigation scientifically and reasonably, and thirdly, the corrective and preventive measures must be in place to conclude the investigation. Zeng Maofa, Dean of Taizhou Food and Drug Inspection Research Institute, emphasized that OOS investigations must find the root cause, adhere to the principle of risk management, draw inferences from one case, formulate an executable plan according to the actual situation of the enterprise, and effectively verify the effect of CAPA. At the same time, he also pointed out that this salon has a good format and good results, which is of sufficient significance for enterprises to scientifically and effectively implement OOS investigation in the process of drug testing.

Li Xiongwei, director of Taizhou Market Supervision and Administration Bureau, emphasized that the leaders of the bureau attached great importance to the salon activities, fully understood the significance of the theme of this salon, fully affirmed the results of the salon activities, and believed that the "OOS Survey" academic exchange salon was very interesting Meaning, the guests have a clearer understanding of the OOS investigation in the drug testing process, and the ability and management level of the OOS investigation should be effectively improved in the follow-up. He emphasized that it is necessary to do a good job in summarizing and improving the exchange results of this salon, so as to achieve experience Reciprocal with the results, to continue this meaningful activity. At the same time, he said that for the past six consecutive years, the Taizhou Municipal Government, industry associations and leading enterprises have built a professional and authoritative communication platform, which has provided rich experience for systematically promoting the improvement of drug quality and achieved good results. He hopes that the participating companies can use the experience and achievements of this salon to lay a solid foundation, make up for shortcomings, strengthen innovation, and promote the level of drug quality management to a new level!