Specifies necessities for a quality management system where an organization requirements to demonstrate its capacity to supply primary packaging materials for medicinal products, which constantly meet client necessities, including regulatory necessities and International Standards applicable to primary packaging materials.

This new edition includes necessities for risk management.
There is an extensive revision regarding verification, qualification and validation necessities for primary packaging materials.
The necessities for infrastructure, work environment, preservation and cleaning activities have been revised. Also the needs for customer communication control of production and service provision and batch release have been customized.