Megha Sinha, founder and CEO of Kamet Consulting Group explains why the systems most manufacturers use to manage post-approval changes are no longer fit for purpose, and what a viable alternative looks like in the AI age.
There is a category of operational risk in pharmaceutical manufacturing that absorbs enormous resources, drives significant cost overruns and creates genuine supply continuity exposure - yet rarely features in boardroom conversations or investor presentations. It is post-approval change management, which sits at the intersection of regulatory affairs, supply chain, quality and manufacturing operations. It is unglamorous, technically demanding and almost universally under-managed. Yet the scope can be all-consuming.