What is the ISO15378 quality management system

The ISO15378 quality management system is an international application standard for pharmaceutical packaging materials. It applies GMP principles and the requirements of the QMS quality management system to the primary packaging materials of pharmaceuticals. Since the primary packaging material is in direct contact with the drug, the GMI principle understood by the organization (enterprise) in the production and quality control of the primary packaging material is very important for the safety of patients when using drugs. The application of GMP for pharmaceutical packaging materials should ensure that these materials meet the needs of the pharmaceutical industry. The key purpose of ISO15378 is to specify a unified requirement for pharmaceutical packaging materials, including some special requirements derived from pharmaceutical GMP production and control.

pharmaceutical packaging

ISO15378

Xinfuda received the ISO15378 quality management system certification issued by the SGS certification body. This indicates that the company has reached international standards in terms of quality management, drug raw material risk control, etc., and will provide more international customers with high-standard and professional services.