A Flexible Regulatory Approach for Different Raw Materials Suppliers Using QbD Principles

Quality by Design (QbD) studies areused in the pharmaceutical industry since 2004. The first step started with the Process Analytical Technologies guideline, which was followed by the International Conference on Harmonisation Q8, Q9, Q10 and Q11 guidelines. During the multi-parameter processes of pharmaceutical production, it is necessary to make different variations in either the formulation or the process. However, these variations cannot be performed without permission of Authorities. Design space is a production space provided by the control of critical parameters that are determined by the formulation and manufacturing process. In addition, working within this Design space is not considered a change. This study is based on the fact that Regulatory authorities do not have to be informed of changes as long as the Quality by Design studies remain within the Design space of the Quality by Design formulations. The objective of this study was to demonstrate the flexibility of post-approval changes on ramipril tablets, which contain components from three different active pharmaceutical ingredient manufacturers, within the scope of the Design space. This information was obtained using artificial neural network programs. The stability of the manufactured tablets was evaluated, the convenience of the Design