ISO 15378 is the international quality management standard specifically designed for manufacturers of primary packaging materials for the pharmaceutical industry. It is a sector-specific version of ISO 9001 (Quality Management) combined with the principles of Good Manufacturing Practice (GMP).
Identifying potential failure points in the manufacturing process before they reach the final assembly or the market. iso 15378 key pointspdf free
ISO 15378 specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide primary packaging materials for medicinal products that meet customer, statutory, and regulatory requirements. The standard is an for the design, manufacture, and supply of primary packaging materials for medicinal products. ISO 15378 is the international quality management standard