EU-GMP Readiness for GACP Sites
We help GACP operations strengthen structure, documentation, and control before buyer audits, EU-GMP scrutiny, and export conversations begin.
Why It Matters
Many supply chain problems begin long before the batch is shipped. They start when a site looks acceptable on paper but lacks the level of control, traceability, consistency, or operational discipline expected by serious buyers and quality-driven partners. That gap often becomes visible only later, when time, money, and commercial trust are already at risk.
STEPS
How the assessment works
01
Initial review
We begin with the essential information needed to understand the site, its current structure, and the context in which it operates. This first phase helps define priorities and identify visible gaps before the on-site assessment.
02
On-site assessment
We visit the site to verify whether documented practices are actually reflected in real operations. This is where structure, behaviour, controls, and consistency are tested against reality.
03
Gap evaluation
We analyse the findings to determine where the operation is strong, where it is exposed, and which issues should be addressed first based on relevance and impact.
04
Action plan
You receive a clear assessment outcome together with practical next steps. The objective is not just to point out problems, but to define a realistic path forward.
Possible outcomes
Ready to move forward
The site shows a solid level of structure and control, with no major issues that would prevent the next stage of qualification or commercial progression.
Ready with corrective actions
The site has a workable foundation but still requires targeted improvements before it can be considered fully ready for the next phase.
Not yet ready
Important weaknesses are present in the system, the operation, or the supporting controls. These issues need to be addressed before the site can move forward with credibility.
What you receive
At the end of the process, you receive a structured readiness picture of the site, a clear view of the main gaps identified, and a practical direction on how to strengthen the operation. The purpose is to support better decisions, reduce avoidable exposure, and create a stronger starting point for future qualification, implementation, or commercial development.
