Wanbande Pharmaceutical Successfully Hosts the 6th Taizhou City Drug Quality Research Salon

On November 5, the 6th Taizhou Pharmaceutical Quality Research Salon, hosted by the Taizhou Pharmaceutical Association and the Pharmaceutical Quality Research Professional Committee, and organized by Wanbangde Pharmaceutical Group Co., Ltd., was successfully held at the Wenling International Hotel. The event aimed to further leverage the power of industry organizations, create a platform for exchange and communication, and share insights and achievements in quality management—thereby injecting momentum into the high-quality development of pharmaceutical companies in our city. This session of the salon focused on an engaging discussion centered around the theme "OOS Investigations."

More than 80 participants attended this session of the salon, including Li Xiongwei, Director of the Taizhou Municipal Market Supervision Administration; Wang Huiqun, Deputy Director; Zeng Maofa, Director of the Taizhou Institute for Food and Drug Inspection; Wang Ping, Deputy Director of the Taizhou Pharmaceutical Certification and Inspection Center; representatives from market supervision bureaus across various districts and counties in Taizhou; Lin Hong, Deputy General Manager of Quality at Wanbangde Pharmaceutical; Hu Shiqin, Deputy General Manager of Administration; and representatives from ten leading pharmaceutical companies that are members of the Pharmaceutical Quality Research Professional Committee under the Taizhou Pharmaceutical Association.

Vice General Manager Lin Hong first extended a warm welcome and heartfelt gratitude to all the distinguished leaders and guests who took time out of their busy schedules to attend the event. She emphasized that the Taizhou Pharmaceutical Association’s establishment of the "Drug Quality Research Salon" platform plays a crucial role in advancing the city’s pharmaceutical production and quality management standards. Through lively academic exchanges, diverse perspectives spark meaningful discussions, fostering rapid consensus while inspiring participants with valuable insights and benefits. Wanbangde Pharmaceutical places great importance on this salon event, having meticulously planned and carefully prepared every detail to ensure its success. She then outlined the six key agenda items for today’s session: a company visit, keynote speeches, presentations by participating enterprises, breakout group discussions, consensus-building recommendations, and closing remarks from leaders. Finally, she sincerely wished everyone a successful and fruitful outcome for this edition of the salon.

Following this, Li Xiongwei, Director of the Taizhou Municipal Administration for Market Regulation, along with more than 80 distinguished guests in attendance, were led by Lin Hong, Deputy General Manager of Quality at Wanbangde Pharmaceutical, and Hu Shiqin, Deputy General Manager of Administration, to visit Wanbangde Pharmaceutical’s fully automated outer packaging production line for Ginkgo Leaf Dropping Pills, as well as the company’s exhibition hall—split into two groups. The guides provided a detailed overview of the company’s development journey, industrial layout, flagship products, and cutting-edge technologies. Attendees were captivated by the charm of Wanbangde Pharmaceutical’s smart manufacturing, marveling at the highly efficient automated equipment and advanced production processes.

Following this, Zhao Shouhu, QC Director at Wanbangde Pharmaceutical, delivered a keynote speech titled "OOS Investigations." He provided a comprehensive overview of the history of OOS cases, outlined the OOS investigation process as defined by the MHRA (UK Medicines and Healthcare products Regulatory Agency), and discussed proactive measures to prevent OOS incidents in daily operations. Additionally, he meticulously compared and contrasted the OOS investigation procedures set forth by the FDA (US Food and Drug Administration) and the MHRA, sharing detailed analyses of common real-world scenarios encountered during investigations. Finally, Zhao also shared Wanbangde Pharmaceutical's own robust processes and valuable insights gained from handling OOS cases over the years. Meanwhile, representatives from various companies took turns presenting their organizations' experiences with OOS/OOT investigations, highlighting the common challenges they face during testing. They expressed hope that these discussions would lead to meaningful resolutions during the upcoming breakout sessions.

During the breakout discussion session, participants from various companies divided into six groups to tackle 21 representative questions submitted earlier by company representatives. These questions covered topics such as OOS investigation principles and procedures, laboratory investigations, and deviation management. Throughout the discussions, each company’s representatives shared their organizations’ respective practices while also voicing their own questions and perspectives. The lively exchange of ideas sparked insightful debates, igniting a vibrant clash of thoughts and innovative solutions. By the end of the group discussions, nearly all participants reached a basic consensus on the key issues. Following the discussions, each group sent representatives to present their findings, sparking further spirited debates with other groups—ultimately leading to a unified agreement. This collaborative exchange not only yielded preliminary solutions to the 21 common challenges presented by the participating companies but also fostered a deeper alignment among attendees regarding OOS investigation practices and workflows in their daily operations. As a result, the overall expertise of investigators was enhanced, and their professional knowledge was significantly enriched. Most importantly, these insights provide invaluable guidance for companies aiming to refine and strengthen the comprehensiveness and thoroughness of their OOS investigation processes and practices.

Following this, leaders from government departments and industry expert representatives delivered concluding remarks, focusing on the common issues and challenges related to the salon’s central theme. They shared their insights and offered practical suggestions. Wang Huiqun, Deputy Director of the Taizhou Municipal Administration for Market Regulation, emphasized that professionals must adopt a rigorous attitude and demonstrate perseverance—like "driving in a nail"—to develop sound operational strategies based on risk management principles, with prevention as the ultimate goal. This session of the salon proved highly beneficial, successfully addressing shared challenges in pharmaceutical production through structured group discussions and fostering consensus among participants. Such collaborative efforts will undoubtedly strengthen the implementation of robust measures aimed at ensuring both safe drug production and stringent quality control. Wang Ping, Deputy Director of the Taizhou Pharmaceutical Certification and Inspection Center, highlighted key considerations for OOS investigations: first, initiating inquiries strictly in accordance with laws and regulations; second, conducting thorough and scientifically sound investigations; and third, ensuring that corrective and preventive actions are well-documented and effectively implemented. Meanwhile, Zeng Maofa, Director of the Taizhou Institute of Food and Drug Control, underscored the importance of identifying root causes during OOS investigations while adhering to risk management principles. He encouraged participants to draw broader lessons from each case, tailor solutions to fit individual company contexts, and rigorously validate the effectiveness of CAPA plans. Lastly, he praised the salon’s format and outcomes, noting that it provided invaluable guidance for companies seeking to conduct OOS investigations in a scientifically sound and efficient manner throughout the drug-testing process.

Li Xiongwei, Director of the Taizhou Municipal Administration for Market Regulation, emphasized the bureau leadership's strong commitment to the salon event, underscoring their deep understanding of the significance behind this year’s theme. He fully acknowledged the success of the event, calling the "OOS Investigation" academic exchange salon highly valuable. Attendees gained a clearer grasp of OOS investigations in pharmaceutical testing processes, and the director stressed the importance of effectively enhancing both the technical capabilities and management standards for handling OOS cases moving forward. He also highlighted the need to meticulously compile and refine the outcomes of this salon, ensuring that insights and achievements are shared and mutually beneficial. Furthermore, he encouraged the continuation of such meaningful initiatives. Additionally, Li Xiongwei noted that over the past six years, the Taizhou municipal government, industry associations, and leading enterprises have collaboratively established a professional and authoritative platform for knowledge exchange. This platform has not only provided invaluable experience in systematically advancing pharmaceutical quality improvement efforts but has also yielded impressive results. Finally, he expressed his hope that participating companies would leverage the insights and successes from this salon to build a solid foundation, address existing gaps, foster innovation, and ultimately elevate pharmaceutical quality management to new heights!