Transforming Pharmaceutical Development: Combining Digital Platforms and QbD Principles

Nowadays, integrating data and digital information, in general, has emerged as a topmost concern for numerous industries, and the Life Sciences sector is no exception. With these, the new challenges and opportunities emerging result in the necessity of continuous adaptation and innovation, particularly in the regulatory field. The International Council for Harmonization (ICH) Quality guidelines comprise a collection of regulatory standards designed to harmonize requirements across regions for the quality of pharmaceutical products. These guidelines aim to safeguard the safety, efficacy, and quality of products throughout their lifecycle.

In this article, we will focus our attention on ICH Q8, Q9, Q10, Q11 and Q14, that highlight concepts related to pharmaceutical development under Quality by Design (QbD) framework, risk management, and development of analytical procedures. Currently, pharmaceutical development is still strongly relying on manual processes, paper-based documentation, and inefficient methods of communication and record-keeping. Such strategies result in high levels of inefficiency and high-skilled workforce disengagement due to excessive time spent. The question we want to address is: How can data and digital further enhance pharmaceutical development and contribute to continuously deliver products in a faster and more efficient way?