The ISO 15378 – Primary Packaging Materials for Medicinal standard was developed by stakeholders in the pharmaceutical sector to provide a quality management system (QMS) for suppliers of materials intended to be used as packaging for medicinal products.
The ISO 15378 standard, mitigates risks especially related to contamination, mix-ups and errors. The ISO 15378:2006 standard includes a number of important QMS guidelines for primary manufacturers of glass, plastic, rubber, aluminum and other materials used for medicinal packaging including：
Compliance to legal requirements
Identification, reduction and control of risks including contamination and manufacturing errors
Improved efficiency and cost-effectiveness in operation
ISO 15378 is International Standard for Primary Packaging Materials for Medicinal Products – Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of the direct product contact. The application of GMP for pharmaceutical packaging materials should ensure that these materials meet the needs and requirements of the pharmaceutical industry.
A key objective of this International Standard is to define harmonized primary packaging material requirements. It includes some particular requirements for primary packaging materials, which are derived from Good Manufacturing Practices for the production, control, etc. of medicinal products.
GMP has been restated as a legal requirement in order to ensure the health of consumers by reducing risk, including contamination and/or mix-ups, in the pharmaceutical and food industries.
First published in 2006, the process-oriented ISO 15378 standard focuses on this perspective. Based on the internationally accepted ISO 9001 quality standard, it contains all of the GMP requirements relevant to primary packaging material, such as batch tracing, risk management, validation, and controlled environment. ISO 15378 applies to all manufacturers of packaging materials that come into direct contact with the medicinal product, e.g. glass, rubber, aluminum, and plastics.
ISO 15378 benefits:
A certificate to ISO 15378, with its holistic approach to GMP and quality requirements, is recognized throughout the world.
Evidence of adherence to legal requirements and contractual obligations
Reduction and control of risks
Clear statement of the organization’s competence
Creates competitive advantages
Improves quality capability
Saves time and costs