ISO 15378 –

Primary Packaging for Medicinal Products

A critical qualification for customer approval

Pharmaceutical companies need to ensure that their own supplier au-

dits fulfill relevant legal requirements; that is why in 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 re-
quirement in order to ensure the health of consumers by reducing the risk of e.g. contamination
or mix-ups in the pharmaceutical and food industries.

Published first in 2006, the process-oriented ISO 15378 standard picks up this idea.
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.

A certificate to ISO 15378, with its holistic approach to GMP and quality require-
ments, is recognized throughout the world. It provides manufacturers of primary
packaging materials with a suitable qualification for customer approval – as well as
improving the organization’s image in the eyes of the authorities. ISO 15378 applies
to all manufacturers of packaging materials that come into direct contact with the
medicinal product. The standard covers all of the usual materials, such as glass, rub-
ber, aluminum, and plastics.

DQS GmbH August-Schanz-Straße 21 Markgrafenstraße 56 Taubenheimstraße 24

Deutsche Gesellschaft zur Zertifizierung 60433 Frankfurt am Main 10117 Berlin 70372 Stuttgart
von Managementsystemen Tel. +49 69 95427-0 Tel. +49 30 200543-30 Tel. +49 711 3807319-0
 Your benefit

„„ 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 Associa-
tion 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 improve-
ment potential. Finally, audits also result in an increased awareness of whether or not the man-
agement system is suitable for achieving the desired results. With value generating audits, the
ideal certification body will provide direction for decision making processes.

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DQS GmbH 03/2009