The ISO Standard 15378 "Primary Packaging Materials for Medicinal Products - Particular Requirements for the Application of ISO 9001:2000 with Reference to Good Manufacturing Practice (GMP)" has been adopted as a European standard by the European Committee for Standardisation (CEN). The Standardisation Organisations in the different EU Countries will withdraw the existing standard. In Germany for example the German Institute for Standardisation (DIN) will withdraw the DIN ISO of June 2006 and plans to publish a version with updated wording in October 2007.

This standard will link the requirements of the known ISO 9001:2000 with specific GMP requirements to manufacturers of packaging materials.

Manufacturers of primary packaging materials will thus have the opportunity to have their QM system certified against the requirements of this standard by an independent certification office. At the same time this standard will become an important yardstick for the pharmaceutical industry, i.e. as a basis for supplier qualification and as a requirement specification for audits of manufacturers of packaging materials.

Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)