Primary packaging for medicines certification ISO 15378
GMP in the primary packaging for medicinal products.
ISO 15378 is a comprehensive and integrated solution to the standard of the ISO 9001 quality management system: 2000 and which combines good manufacturing practice of pharmaceutical primary packaging materials.
In addition to the full requirements of ISO 9001: 2000, ISO 15378 contains relevant information for the design, manufacture and supply of packaging materials for medicinal products.
These GMP are based on a scientific balance, practical and economical, agreed following extensive consultations and comments of the leading players.
In line with current developments in the world, the standard also contains guidance annexes relating to risk management and validation.
The standard is a fundamental tool for purchasing managers, Packaging Development, Supply Chain Management, Quality Assurance and especially control.
ISO 15378 can be used for quality improvement, training, auditing and certification.