Pharmaceutical companies to participate in drug production site management GMP training


Release time:

2019-10-21

From September 26 to 28, Jianfeng Pharmaceutical Factory organized workshop management personnel and QA to participate in the training of "Drug Production Site Management and Analysis of Common Defects in Production System" organized by Feitian Education Group in Hangzhou to learn about the site management of drug production, analysis of common defects in production system and requirements for equipment documents and data integrity in production system.

In the process of FDA certification, EU certification and China certification, more and more inspectors pay attention to the GMP compliance inspection on the production site. This training mainly focuses on the link design of quality control in the whole process of drug production. The training takes some practical cases as the starting point to help enterprises improve drug quality, on-site management related to production process control, key control and defect analysis in the production process, and reduce the risks of confusion and errors in the drug production process.

The main contents of the training include comparative analysis of similarities and differences among FDA, EU and China GMP, analysis of defects related to production process in official inspection and audit at home and abroad, key points and precautions of production site inspection, design points and practical analysis of batch production process control records based on different registered processes, management requirements of production equipment, management of production-related documents and records, and data integrity management requirements in production system.

Through the training, the trainees of the peak pharmaceutical factory increased the knowledge of drug production site management, production system equipment and documents and data integrity requirements, broadened their horizons, inspired ideas to solve common defects in the production system, and deepened their understanding of GMP.

After the training, the trainees also exchanged and discussed some problems in the production site management of the enterprise with the training teachers.