W 02: End-to-End Change Control: An Integral Approach to Product Changes, Submissions, and Variation Management
Deloitte United States
1. To explain the basic concepts of End-to-End Change Control
2. To provide insights into some of the key benefits and challenges relating to End-to-End Change Control
According to the EU Guideline Annex 16, as well as 21 CFR 211, the MAH has the responsibility to ensure that a particular batch has been manufactured in accordance with its marketing authorization.
However, the current procedural and technology landscape, to manage product changes from initialization, via regulatory approval, and up to release of the updated product into the supply chain, is very fragmented, as well as being decoupled and functionally compartmentalized.
Although historically explainable, this traditional way of working is very time consuming, inefficient, and leaves a lot of room for error, miscommunication, and associated rework; sometimes even leading to unnecessary recalls.
Having full visibility over changes and associated approvals, pending or approved, across all markets; and providing full control over products released into those same markets is key to making many recalls something of the past.
Now with the introduction of standardized product information, i.e. IDMP, and associated newly formed, or to be formed, technologies, industry as well as agencies can start their transitions to more robust and transparent processes to manage and control the flow of product information and associated product changes end-to-end.
Implementing these concepts will not happen overnight, but the business case is there so, maybe, it is time for planting the seeds and to discuss, conceptually, how this could work.