Quality by Design in Pharmaceutical Packaging

It is imperative that a safe and effective medication product be produced not only with high-quality ingredients but also with acceptable packaging components since those components are in direct contact with the medication. An interaction between major packaging components and the therapeutic product may result in failure to meet the quality target product profile (QTPP). It is possible to avoid this by implementing a Quality by Design (QbD) strategy. QbD is a systematic development method that starts with established objectives and focuses on product and process understanding and process control, all of which are founded on strong science and quality risk management. Critical Quality Attributes (CQAs) are physical, chemical, biological, or microbiological features or characteristics that must fall within a specific limit, range, or distribution to ensure the intended product quality. During the packaging component selection process, QbD can assist in establishing a link between the materials attributes of packaging components and the quality of the medicinal product. Monitoring specific quality parameters of the medicinal product can help assess the influence of each type of packaging component. QbD has been extensively discussed, primarily in the context of pharmaceutical formulation manufacture. However, QbD applications for pharmaceutical packaging are not generally sought. This chapter is only concerned with the application of QbD to the pharmaceutical packaging subset of dosage forms.