From March 1st to March 2nd, Wanbangde Pharmaceutical Group held a two-day training seminar with the theme of change control and OOS management, aiming to improve the company's drug production quality management level and solve the problems in the implementation process of the new version of GMP for drugs. The key issue. This training seminar invited teachers Zhao Qian and Jia Yaping from Shanghai Tufa Pharmaceutical Technology Co., Ltd. to give lectures. More than 90 managers and technicians from the headquarters of Wanbangde Pharmaceutical Group and the technical system, production system, quality system, administrative personnel, procurement and sales, materials and other departments of the API factory participated in the training activity.

Change control runs through the entire life cycle of the drug, and change control management has a great impact on the safety, efficacy and quality control of the drug. On March 1st, Mr. Zhao Qian explained the relevant knowledge of change control management in a comprehensive and systematic manner. The training content is from simple to deep, with the theme of my country's "Technical Guidelines for Research on Changes in Production Processes of Listed Chemicals", combined with the ICH, EU and FDA change guidelines, from the scope of application, risk assessment, change assessment, change type and document requirements, Report categories and other aspects comprehensively analyze the process and importance of change control management. It focuses on the purpose, use conditions, process and specific implementation measures of change control in terms of facilities, equipment changes, quality standard changes, production process changes, starting material changes, and container sealing system changes. In the lecture, Mr. Zhao Qian, through special explanations, group discussions, practical exercises, etc., allowed all the participants to find out the existing problems in time, and gave them answers and answers, in order to improve the internal change control ability of Wanbangde Pharmaceutical Group through this training. .

On March 2, Mr. Jia Yaping started from the four aspects of OOS history, OOS treatment process, microbial OOS (MDD), and OOS in the FDA warning letter, combining theory with practice, using a large number of FDA classic cases, and combining OOS in the company's production process. As a result, the investigation and disposal procedures were analyzed, and the essence of OOS management was systematically described, and the trainees were given a novel and substantial theoretical class. The employees on the scene benefited a lot and seized it. Opportunities to actively interact with teachers up close.

"Hearing is not as good as seeing, and seeing is not as good as doing." Although the training was short-lived, the participating employees saw their own shortcomings and clarified the direction of progress and efforts. Through the training, the employees were further familiar with the knowledge of change control and OOS management, mastered the specific working methods and steps, and laid a solid foundation for the quality management in the pharmaceutical production process.

Lin Hong, deputy general manager of quality, said that compared with European and American countries, domestic companies still have relatively weak links in the standardized management of drug GMP. At present, we have systematically trained and improved the company according to international standards, so that the company can better comply with international GMP. requirements, to provide a strong guarantee for the company's products to enter the international market in the future.

Wanbangde Pharmaceutical Group conducts special training on change control and OOS management

Group study and discussion of trainees (1)

Group study and discussion of trainees (2)

Group study and discussion of trainees (3)

Group study and discussion of trainees (4)

Group study and discussion of trainees (5)

Group study and discussion of trainees (6)