Implementation of QbD Paradigm In Sterile Dosage Form Packaging – Some Practical Considerations

Out of all the pharmaceutical dosage forms, the Quality Target Product Profile (QTPP) for the sterile dosage form is the strictest for obvious reasons. One has to pay attention to the critical quality attributes (CQA) to a great extent. This presentation is focused only on the packaging of sterile dosage forms. There are several types of sterile dosage forms such as small and large volume parenteral liquids, lyophilized products, ophthalmic solutions/suspensions etc. The packaging is different for each type. The Quality by Design (Qbd) approach should be applied during the packaging operation (identification, management and control of packaging operation). Leachables and extractables are critical in other dosage forms, but are most important in sterile dosage forms. QbD should also consider other aspects including – uniformity of distribution, pH, sterility, particulate matter, water content, antimicrobial and antioxidant preservative content, osmolarity, and endotoxins/pyrogens. In this seminars topics such as development of design space for packaging, influence of scaling up, design of clean room, environmental monitoring and aseptic processing will also be discussed. Important, design and interpretation of media fills will also be discussed to build in quality by design.