ISO 15378 – The adaptation of ISO 9001 for the production of primary packaging materials for medicines

The standard applies to companies producing primary pharmaceutical packaging materials and sets out good manufacturing practices for the design, manufacture and distribution of such materials. The standard incorporates the quality management requirements of ISO 9001 and includes additional requirements concerning:
• The specifications that pharmaceutical packaging materials must comply with
• Requires them to avoid contamination during the production process
• The verification and validation of drug packaging materials
• The preparation of a risk management study
• The requirements for printing
The application of the standard improves the level of control of the production process as it will be carried out based on specific requirements of good practices while also improving the efficiency of the operations.
PRIORITY having developed a large number of quality management systems, is able to help the company with effective solutions and good practices by reducing bureaucracy in the daily life of staff.

Do you want to discuss about your needs and provide you the right solutions?

BSc in Computer Science, University of Crete, and MSc in International Marketing, University of London. She is experienced in auditing Management Systems and has been working for more than a decade in international group of companies, specializing in the sector of Sales, Marketing and Corporate Communication.
Lilly Mylona
Sales, Director

Contact with

Mrs. Lily Mylona,

Sales Director, PRIORITY

[email protected]

T. 210 2509900