The standard is of crucial importance for the pharmaceutical industry and its suppliers of primary pharmaceutical packaging materials. For the first time, the principles of good manufacturing practice are defined within the framework of an ISO standard," explains Dr. Jürgen Thürk, convenor of the working group, which has developed the new standard.

Good Manufacturing Practice (GMP) refers to quality control and quality assurance, which enables pharmaceutical companies to minimize or eliminate cases of contamination, confusion and errors. This in turn protects the customer from the purchase of a product that is ineffective or even dangerous. Until now, however, there has been no applicable directive or rule for primary packaging materials that contain, seal or be used for dose application and have direct contact with the drug.

The publication of ISO 15378: 2006, Primary Packaging Materials for Drugs Special requirements

For the application of ISO 9001: 2000 constitute an international consensus on best practices and represent a benchmark that can be used for quality improvement, training, auditing and certification.

Developed with the participation of pharmaceutical industry experts, ISO 15378: 2006 contains, in a single document, the quality management requirements of ISO 9001: 2000 together with the principles of good manufacturing practice (GMP) for the planning, production and delivery of primary packaging materials for medicinal products.

In addition, the new standard gives guidance on risk management and validation and in accordance with current developments worldwide, there are guidance on these two aspects.