This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. In this International Standard the term if appropriate is used several times. When a requirement is qualified by this phrase, it is deemed to be appropriate unless the organization can document a justification otherwise.
Diese Internationale Norm legt Anforderungen für ein Qualitätsmanagementsystem fest, bei dem eine
Organisation ihre Fähigkeit nachweisen muss, Primärpackmittel zur pharmazeutischen Verwendung zu
liefern, die stets den Anforderungen der Kunden inklusive den gesetzlichen Bestimmungen und den auf
Primärpackmittel anwendbaren Internationalen Normen entsprechen.