There are a number of interpretations of the term ‘lifecycle’, ranging from NIPTE’s all-encompassing Design-Development-Manufacturing on the one hand, to ISPE’s more focused Commissioning & Qualification on the other.
My contention is that within the transition state, Lifecycle Unification principles can be applied to simple and complex situations alike; complex lifecycles being treated as concatenations of simpler phases and sub-phases.
FDA’s Target Product Profile (Draft Guidance, Mar 2007) provides a current and relevant benchmark in support of this argument, with its emphasis on development milestones/endpoints and the provision of ‘a dynamic summary that changes as knowledge of the drug increases’.
With the TPP example in mind, here are three suggested rules in support of Lifecycle Unification within the transition state.
- Individuate your phases & sub-phases within a shared interdisciplinary framework
- Register your systems & components as a function of phase (e.g. tech transfer, design, operation, aftercare)
- Create class-based rules enabling systems & components to inherit standardized procedures across their lifecycles
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