Drug development leaders must consider robustness and quality initially during formulation development. In the past, pharmaceutical researchers often did not have a common R&D quality framework for developing robust formulations and manufacturing processes. Consequently, quality was ensured through QC analytical testing. However, in cGMP manufacturing, this leads to expensive batch failure and troubleshooting resulting in delayed start of clinical studies for NDA filing or pharmaceutical supply disruption for approved products. Furthermore, QC statistically cannot always ensure compliance of every single tablet, capsule, bottle, or vial.


Guidance documents such as ICH PHARMACEUTICAL DEVELOPMENT Q8(R2) provide a detailed framework for implementing rigorous quality standards during pharmaceutical drug development. The framework consists of first carefully thinking through and documenting the design criteria, clearly identifying critical quality attributes (CQAs) of the product that have a major influence on the drug product’s quality and taking a structured approach to risk assessment and risk management during R&D. Such an approach reduces costly and time-consuming OOS investigations (out of specification) due to dissolution failure, product stability failure, microbial contamination, or other noncompliance issues during cGMP clinical and commercial batch manufacturing.