Vincent L Vilker and Mansoor A Khan, CDER/FDA
The increasing sophistication of modern drug products is leading to unprecedented challenges and opportunities for pharmaceutical manufacturing. At the same time, scientific and technological advancements in analytical instrumentation, coupled with implementation of the principles embedded in quality by design, enable the improved process monitoring and control that lead to better and more consistent product quality. ICH Q8(R2), the first of three International Conference on Harmonization (ICH) Guidance for Industry that spell out the concepts of Quality by Design, states that critical formulation attributes and process parameters should be identified through an assessment of the extent to which their variation can have impact on the quality of the drug product. In this presentation, examples will be given where modern instrumentation and manufacturing practices are required to maintain the critical formulation attributes of several drug products that have unique physicochemical and/or biological properties. Examples may include properties such as very low solubility, polymorphic solid states, poorly defined macromolecular size distributions, or where there is a tendency to become unstable in the formulated product.