ISO 15378

ISO 15378 – Primary packaging materials for medicinal products are developed by the interested parties in the pharmaceutical sector and provide quality management systems (QMS) to suppliers of materials to be used for packaging of medicines. You can reduce the risk of contamination, mixing and error, especially when certifying operations to ISO 15378 standards. It also ensures that your clients comply with QMS.

It provides reliable and independent ISO 15378 certification for manufacturing of pharmaceutical packaging materials. Identify strengths during audit before certification and analyze your operations by summarizing areas that need improvement. We understand the exact meaning of all aspects of your manufacturing process and standards.


The ISO 15378:2006 standard includes several important QMS guidelines for major manufacturers of glass, plastics, rubber, aluminum and other materials used in medicine packaging, including:




Benefits of certification:

-It helps pharmaceutical organizations minimize or eliminate contamination, mixing and manufacturing errors.

- Provides guidance about risk management and verification

- Improve the efficiency and cost efficiency of your business operations.

- It continuously meets customer requirements, including regulatory requirements.

- Competitive advantage



The ISO 15378 standard has been developed by the pharmaceutical interested parties to provide quality control systems (QMS) to material suppliers who want to use it as a packaging material.

First published in 2006, ISO 15378 standard is integrated into a single document related to the design, manufacture and supply of base packaging materials for Good Manufacturing Practice Principliers of GMP (Good Manufacturing Practice Principles of Good Manufacturing Practice) with the quality management system requirements of ISO 9001.

The application of GMP principles provides assurance that pharmaceutical packaging meets regulatory and pharmaceutical industry requirements.




ISO 15378 specifies requirements for QMS to demonstrate its ability to continuously provide primary packaging materials for medicines.

In addition to the requirements contained in ISO 9001:2000/2008, ISO 15378 applies to key packaging sectors such as risk management, batch / lot tracking, verification of critical processes and environmental control.



Accreditation to this standard provides additional assurance to the customer of quality products. Certification in these standards also enables organizations to achieve quality objectives and objectives and to continually improve manufacturing processes.

- Complies with legal requirements

- Identify, reduce and control risks including contamination and manufacturing errors

- Improved efficiency and cost-effectiveness in your work.