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Lifecyle management has always taken the lion share of resources for any regulatory department – both in terms of time and costs. The ICH Q12 guideline is meant to facilitate the management of post-approval changes in a more productive and efficient manner, thus helping both regulators and pharma companies alike manage their resources more effectively. However, it has taken almost 5 years to reach consensus on the final guidance document. Thankfully, agreement is now expected later this year on this important quality standard, under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The aim of Q12 is to establish a framework for managing post-approval manufacturing changes in multiple regions. While all post-approval changes must be managed and documented, not all require prior approval by regulatory authorities. Added important benefits would be to mitigate drug shortages and to encourage the adoption of innovative manufacturing technologies.
The current Q12 document describes a risk-based system for categorising changes, building on existing policies in the United States, Japan, and the European Union, but not in all regions. A main element of Q12 is to define those “Established Conditions” where chemistry, manufacturing, and control (CMC) changes require regulatory submissions and approval. While everything in product development is subject to change control, only certain elements need to be reviewed. The new standard also encourages manufacturers to devise post-approval change management protocols (PACMPs) that describe in advance those changes that a firm anticipates it will implement during the product lifecycle, and how it proposes to report such changes. PACMPs exist in the EU and US, but have not been widely used; agreement on common approaches to lifecycle management aim to encourage broader adoption of such approaches. This initiative appears particularly important for a company that anticipates shifting production to a new facility, especially when involved in accelerated development of a breakthrough therapy.
To reach final consensus, the experts see a need to more clearly articulate the benefits of developing lifecycle management strategies. They seek further agreement on where this information should go in the common technical document (CTD) and how to present PACMPs, particularly when multiple changes are anticipated for a single product. Future efforts will extend these change-management principles to biotech products and vaccines, and to drugs already on the market. Publication of Q12 will be an important step toward international harmonisation and will provide a common framework for defining established conditions and change protocols. This could possibly lead to more uniform risk tolerance among regions, but differences may remain for some time in how regulators define these terms and other specifics. ELC Group is currently monitoring developments in ICH Q12 and has already helped advise clients on their product development, PACMPs and lifecycle management in order to reap the benefits of this new change in the regulatory landscape.