Julien is CMC Regulatory Strategy Lead, Mundipharma, UK.
A regulatory view on the change management process for medicinal products
An effective change control process is a critical part of good manufacturing practice (GMP), during the post-approval phase of a medicinal product’s lifecycle. This article reviews key aspects of the current EU and International Conference on Harmonisation (ICH) quality guidelines. The operational aspects of the change control process are explored and guidance is provided on how the strategic review of changes can avoid or minimise the regulatory impact.