Company Conducts Special Training on Medical Device GMP to Strengthen Product Quality and Safety Defense Line

In order to thoroughly implement the requirements of the "Good Manufacturing Practice for Medical Devices" (GMP) and its supporting appendices, further improve the operation level of the company's quality management system, and strengthen the quality compliance awareness of all employees, Hubei Yirun Medical Products Co., Ltd. recently organized a special training session on medical device GMP. Personnel from relevant departments including the company's management representative, quality, production, research and development, procurement, warehousing, and sales participated in the training.

This training closely followed the requirements of medical device lifecycle management, covering the general provisions of GMP and chapters including organization and personnel, premises and facilities, equipment management, document management, design and development, procurement control, production management, quality control, sales and after-sales service, control of nonconforming products, adverse event monitoring, and analysis and improvement. The instructors, combining the company's product characteristics, process flow, and key points of routine supervision and inspection, provided a systematic explanation of key content such as regulatory clauses, implementation standards, record filling, data integrity, clean area management, process water, sterilization control, batch production records, and inspection release. Through typical case analysis, interpretation of common deficiency items, and on-site Q&A, they helped trainees accurately grasp regulatory requirements and clarify job responsibilities and operating procedures.

During the training, trainees listened carefully and actively interacted, exchanging views with the instructors on doubts and difficulties encountered in actual work. After the training, the company organized an on-site assessment to test the learning results and further consolidate the training outcomes. Everyone agreed that the training content was detailed and highly targeted, and had important guiding significance for improving daily compliance operations and quality management capabilities.

A relevant person in charge of the company stated that the quality and safety of medical devices concern public health and the long-term development of the enterprise. GMP is not a one-time compliance target, but a systematic project requiring continuous improvement and full participation. Next, the company will take this training as an opportunity to continuously improve the training plan, regularly carry out regulatory update learning, internal audits, and self-inspection and rectification, and promote the implementation of GMP requirements in all links including research and development, production, quality control, warehousing, sales, and management, so as to effectively ensure product quality safety, effectiveness, and compliance.