Transforming Pharmaceutical Development: Combining Digital Platforms And QbD Principles

Today, the integration of data and digital information has become a primary concern for many industries, including the Life Sciences sector. This integration brings both new challenges and opportunities, necessitating ongoing adaptation and innovation, particularly in regulatory practices.

The International Council for Harmonization (ICH) Quality guidelines provide a set of regulatory standards aimed at aligning requirements across regions to ensure the quality of pharmaceutical products. These guidelines are designed to protect product quality, safety, and efficacy throughout the lifecycle. This article delves into ICH Q8, Q9, Q10, Q11, and Q14, which emphasize principles related to pharmaceutical development within the Quality by Design (QbD) framework, analytical procedure development, and risk management.

Pharmaceutical development heavily relies on manual processes, paper-based documentation, and inefficient communication and record-keeping methods. This leads to significant inefficiencies and disengagement among highly skilled workers as a result of the excessive time spent on these tasks. How can data and digitalization further improve pharmaceutical development and the continuous, quick, and efficient delivery of products?