Fran DeGrazio

VP, Scientific Affairs & Technical Services

April 12, 2012

The Next Generation Approach to Elastomeric Closures for Sterile Products

The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs to provide a product that meets payer’s requirements and facilitating profitability in order to continue adequate business reinvestment.

To balance these priorities effectively, the adoption of Quality by Design (QbD) concepts is gathering momentum within the industry. A process designed with QbD principles requires a significant up-front investment. However, it delivers an improved, data-driven output providing manufacturers with superior product and process understanding that minimizes process risk, emphasizes patient-critical quality requirements and enhances drug product effectiveness. A more efficient and controlled process, results in a final deliverable that is a much higher-quality product with well understood and controlled sources of variation.

The Quality Target Product Profile (QTPP) forms the basis for drug product formulation and process development in a QbD concept. A series of considerations should be made for the QTPP of a sterile product. Some of these considerations include the desired product performance based on the intended clinical setting, dosage strength and delivery mode, pharmacokinetic characteristics, drug product quality criteria, sterility and the container closure system itself, just to mention a few.

Quite often, the container closure system is a final consideration in the drug development process. However, the primary package is critical to the success of drug stability and the effectiveness and compliance of a commercial manufacturing process. Realistically, the QbD framework can be adopted by pharmaceutical industry suppliers in order to provide benefits to the pharmaceutical drug manufacturer.

High-quality components and sterile packaging must be well-understood to provide significant benefit to the overall container closure or delivery system.

Watch for a new product from West based on the QbD concept – coming next week!