ISO 15378:2011 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.
ISO 15378:2011 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes.
Who should opt for ISO 15378:2011 certification?
Pharmaceutical / Medicine Packaging manufactures should opt for this ISO certification. For example, A full range of controlled atmosphere packaging solutions, including pharmaceutical desiccants, equilibrium sorbents, adsorbent polymers, oxygen scavengers and pharmaceutical closures and containers manufacturer should opt for the same.
Nowadays with stringent regulatory norms, pharmaceutical companies opt for standard packaging materials which are manufactured under proper quality management system. The main objective is to reduce the batch to batch packaging material quality variation. ISO 15378:2011 certification provides a defined quality management system for the pharmaceutical / medicinal packaging supplier.