ISO : 15378 (Medical Packaging)
ISO 15378:2011 specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organisations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products. The standard delineates GMP principles and specifies QMS requirements pplicable to primary packaging materials for medicinal products.
- Increases the possibility of entering several markets around the world.
- Improves welding quality.
- Decreases quality defects and maintenance costs.