By Andrew Chang, Ph.D., Novo Nordisk Inc.
Today’s pharmaceutical industry is evolving rapidly. Advancements in science and technology are breathing new hope into addressing unmet patient needs with highly innovative treatments. Yet, even with these groundbreaking developments in patient treatment, diverse regulatory environments across the globe create unnecessary burdens on pharmaceutical product lifecycle management. These include, but are not limited to, post-approval changes made for continuous improvement or for expansion of manufacturing capabilities for global product supply. These burdens create the need for a harmonized, risk-based, efficient, and predictable regulatory guideline for pharmaceutical product lifecycle management.
Between 2003 and 2012, the International Conference of Harmonisation (ICH) developed its Q8 through Q11 guidelines to emphasize a science- and risk-based approach for pharmaceutical quality. ICH Q8 through Q11 focused mainly on the early stages of the product lifecycle, but there has been significant process since their creation. The ICH recognized a need for a new guideline that focused on the commercial manufacturing phase “to improve execution and communication of science and risk-based assessments that enable product life cycle management.”1 The result was the ICH Q12 technical and regulatory considerations for pharmaceutical product lifecycle management guideline, which builds on the principles outlined in previous ICH guidelines. Q12 is intended to “demonstrate how enhanced product and process knowledge contribute to a reduction in the number of post-approval regulatory submissions.”2