From a customer/patient point of view, the quality and safety of a drug product is often linked very close to the quality and appearance of the container closure system. Drugs administered with self-injection devices by non-professionals are encumbered with a much higher risk profile than drugs administered by professionals.
This is due to the facts that the common, non-professional user may not have the same practice of use, nor the same competence or awareness to assess whether the closure integrity of the container closure system or the function of the self-injection device may be impaired prior to use.
In order to mitigate the increased risk and meet the high expectations and derived quality requirements to the primary packaging materials, the pharmaceutical industry must apply a total quality view on primary packaging.
What are the regulatory requirements to primary packaging and how is an appropriate quality level achieved in practice.