ISO 15378

ISO 15378:2006

Pharmaceutical companies need to ensure that their own supplier audits fulfill relevant legal requirements. This is why when selecting a supplier of packaging materials, particular attention needs to be paid to their ability to fulfill current GMP requirements. GMP (Good Manufacturing Practices) 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

Conformity and value generation

DQS was the first certification body to become accredited for ISO 15378 by the German Association for Accreditation (TGA) in July of 2007. With an independent and expert assessment of their management system, top management can be sure that the system is in conformance with the requirements of the standard. In addition, the auditors will focus on the identification of improvement potential. Finally, audits also result in an increased awareness of whether or not the management system is suitable for achieving the desired results. With value-generating audits, the ideal certification body will provide direction for decision making processes.