Practical Application of Q8 and Q9 Principles in Pharmaceutical Development

The presentation “Practical application of Q8 and Q9 principles in pharmaceutical development” gives an overview of the current practice in pharmaceutical development within the Oral Solid Dosage form Development department of Abbott in Weesp, the Netherlands. The presentation starts at the point where the prototype formulation, the Target Product Profile and Critical Quality Attributes are known and focuses on process development using risk based approaches. The use of the broad experience of the development and production of similar process and / or formulations is the start of the process development. A cause and effect analysis (brainstorm session) was performed with a group of scientists and engineers, maximizing the amount of knowledge. After prioritizing the results, the potential critical (process) parameters were known. These parameters formed the basis for developing new scientific knowledge. Risk analysis performed at several stages during the development process gives a presentation of the progress of the development, and the identification of Critical Process Parameters. Design Space and Operating Range was defined for controlling the Critical Process Parameters based on scientific knowledge.