Greenfield facility
New facility on a new site
A new regulated facility built on a bare or non-GMP site — the fullest expression of the lifecycle, running every one of the 16 phases from business case to close-out with no existing operation to work around. It carries the most design freedom of any archetype and, with it, the most scope, the longest critical path, and the most first-time risk.
What this page does not claim
The phases and the seams between project management and GxP are SPEQ’s synthesis, not any body’s published method. The sources it draws on are cited and verified; the arrangement is SPEQ’s.
A complete facility built from the ground up for regulated production
Every lifecycle phase in play, from site selection through commercial start-up to close-out
The design freedom to build contamination control and qualifiability in from concept
A new organisation, new systems, and a site with no prior inspection history
Of the 16 lifecycle phases, these carry the most weight for this archetype. See them in context on the full lifecycle.
Choose a location that can be built, staffed, supplied, and inspected for the intended product and markets.
open the phase cluster →Turn user requirements into a design concept whose critical aspects are identified by quality risk before detail locks in.
open the phase cluster →Verify and document that direct-impact systems are fit for their intended GMP use, and release them for use.
open the phase cluster →Assemble the regulatory evidence and prepare the site so the market authorisation and inspection succeed.
open the phase cluster →- Concept and flow decisions that cap contamination control for the facility’s life
- Schedule risk across a long, dependency-heavy critical path with little float
- A first-of-its-kind site with no inspection history and an unproven organisation
- Operational readiness lagging construction, so a qualified asset stalls at start-up
Greenfield is the baseline every other archetype is measured against — maximum design freedom, maximum scope, the longest critical path, and the fullest set of phases. Every other archetype is, in effect, a greenfield project with some phases removed, constrained by an existing operation, or weighted toward a particular slice of the lifecycle.
FREQUENTLY ASKED
Why is a greenfield project the "full" lifecycle?
Because there is no existing operation to inherit or work around, a greenfield facility runs every phase in full — site selection, concept and detailed design, construction, commissioning and qualification, process validation, operational and regulatory readiness, start-up, and close-out. That completeness is also its risk: the critical path is long and dependency-heavy, and early concept decisions set limits that persist for the asset’s life.
Where do greenfield projects most often go wrong?
In the earliest phases. Flow, segregation, and classification decisions made at concept set the contamination-control ceiling permanently, and a design frozen without design qualification exports its gaps into construction and C&Q, where they cost far more to fix. Quality in the room from the business case is the cheapest risk control a greenfield project has.