Wanbangde Pharmaceutical Group Conducts Specialized Training on Change Control and OOS Management

Date:

01 Mar,2021

From March 1 to March 2, Wanbande Pharmaceutical Group hosted a two-day training seminar focused on change control and OOS management. The event aimed to enhance the company’s pharmaceutical production quality management practices and address critical challenges encountered during the implementation of the new version of GMP standards. The seminar featured instructors Zhao Qian and Jia Yaping from Shanghai Tufa Pharmaceutical Technology Co., Ltd. Over 90 managers and technical staff from various departments—including the technical, production, and quality systems at Wanbande Pharmaceutical Group’s headquarters and API plant—as well as representatives from administrative HR, procurement, sales, and materials teams, participated in the training.

Change control is integral to the entire lifecycle of a pharmaceutical product, and effective change control management significantly influences the safety, efficacy, and overall quality control of drugs. On March 1st, Professor Zhao Qian delivered a comprehensive and highly focused presentation on change control management, covering both foundational concepts and advanced topics. The training session was structured from basic principles to more complex insights, centering around China’s "Technical Guidance Principles for Research on Manufacturing Process Changes of Marketed Chemical Drugs." Drawing on guidelines from ICH, the European Union, and the FDA, Professor Zhao thoroughly analyzed the process and importance of change control management—covering aspects such as scope of application, risk assessment, change evaluation, types of changes, documentation requirements, and reporting categories. A particular emphasis was placed on explaining the objectives, applicable conditions, procedures, and practical implementation strategies for managing changes in areas like facility and equipment modifications, quality standard adjustments, production process alterations, raw material substitutions, and container-sealing system upgrades. Throughout the session, Professor Zhao employed interactive methods—including focused lectures, group discussions, and hands-on exercises—to help participants promptly identify potential challenges and address their questions, ultimately aiming to enhance Wanda Pharmaceutical Group’s internal capacity for robust change control management.

On March 2, Teacher Jia Yaping delivered a comprehensive session on OOS management, covering four key areas: the history of OOS, the OOS handling process, microbial OOS (MDD), and OOS-related warning letters from the FDA. She skillfully connected theoretical concepts with real-world scenarios, drawing from numerous classic FDA cases and integrating them with the company’s own procedures for investigating and addressing OOS results during production. Through a meticulous, step-by-step approach that peeled back layers of complexity, she systematically unveiled the essence of effective OOS management. Attendees found the lecture both innovative and highly informative, eagerly seizing the opportunity to engage directly with the instructor and participate in lively discussions.

"As you hear it is not as good as seeing it, and seeing it is still not as good as experiencing it firsthand." Although this training session was brief, the participating employees gained valuable insights into their own areas for improvement and clearly identified the path forward—and the efforts needed—to move ahead. Through the training, they deepened their understanding of change control and OOS management, mastering specific work methods and procedures, thereby laying a solid foundation for effectively managing quality throughout the pharmaceutical production process.

Vice President of Quality, Lin Hong, stated that compared to companies in Europe and America, domestic enterprises still have relatively weak areas in the standardized management of pharmaceutical GMP practices. Currently, we are conducting systematic training and internal improvements aligned with international standards, ensuring the company better meets global GMP requirements—and ultimately providing a strong foundation for our products to enter international markets in the future.