Lifecycle management concepts from ICH Q12 adopted
Ergopharm has adopted the lifecycle-management concepts of ICH Q12 into its change control system, distinguishing the elements of a process that constitute established conditions from those that can be managed within the quality system.
The practical question in any change is: does this need to be notified to the markets we supply, and if so, before or after implementation? Q12 provides vocabulary for that question through established conditions — the elements that a regulatory filing commits to — and through post-approval change management protocols that agree in advance how a defined change will be handled.
“The hardest part of a change is not making it. It is knowing who must be told, and when.”
Because Ergopharm manufactures for partners who hold the marketing authorisations, the regulatory impact assessment in every change now asks explicitly which partner filings are affected and what each partner must be told, and when.
Change notification commitments to partners are set out in the quality agreement rather than negotiated after the fact.
Key facts
- Concept
- Established conditions; post-approval change protocols
- Applied in
- Regulatory impact assessment within change control
- Because
- Partners hold the marketing authorisations
- Commitments
- Change notification defined in the quality agreement
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.