On August 5, 6 and 7, 2022, the audit team led by Zhu Jianping audited our ISO15378 quality system on behalf of China Quality Center. The main purpose of the audit is to evaluate the implementation of the management system, including its effectiveness, to determine whether to recommend certification.

The ISO15378 system (hereinafter referred to as "GMP for drug packaging materials") is to maintain the quality of packaging materials (hereinafter referred to as "drug packaging materials") in direct contact with drugs during the supply process, helping to manage the design, research and development, manufacturing and supply of drug packaging materials. It pays attention to the risk management, traceability and safety of drug packaging materials to avoid pollution, cross contamination/confusion and human error. At the same time, ISO15378 is also the basic requirement of drug manufacturers for high-end drug packaging material suppliers.

The production quality management system standard of direct contact drug packaging materials (hereinafter referred to as "drug packaging materials"), ISO 15378, was issued by the 76th Quality Technical Committee of the International Organization for Standardization (ISO/TC 76) in 2011, 2015 and 2017. The ISO 15378 standard is based on the basic principles of drug GMP, and is formulated with reference to the framework and quality management principles of the ISO 9001 quality management system. It is a special requirement for the application of the ISO 9001 quality management system in drug packaging materials. It fully considers the industry particularity of drug packaging material manufacturers and the high requirements of product quality and safety, and is applicable to organizations of any size around the world.

The initial audit of ISO15378 was successfully completed.