Guide
You are building a GMP plant or a new production line: which stages lead up to the first inspection?
For a new plant or a new line, investment planning, qualification, contamination control, validation and inspection preparation depend on each other. The stages are listed here in their typical order, each with a link to the expert page; qualification already starts with the engineering design.
Typical triggers
- A new plant, a new building or a new line for GMP manufacturing is being planned, for a new product or for more capacity.
- Construction is underway, and the qualification documentation is not keeping pace with it.
- The first inspection of the new operation by the authority is coming up.
Last updated: October 19, 2026
The path in 5 stages
Stage 1
Plan the investment and fix the requirements
At the end stand the business case on capacity, site and make-or-buy and the requirements for the facility, against which tendering, contract award and qualification are measured. The most expensive decisions are made before the first piece of equipment is ordered.
Stage 2
For sterile manufacturing: design contamination control
For sterile medicinal products, the contamination control strategy that Annex 1 requires is in place: cleanroom design, personnel and material flow, cleaning and monitoring in one concept. The choice between isolator and RABS comes before tendering, because the requirements from the first stage already have to take up Annex 1; the Annex gives neither technology precedence.
Stage 3
Qualify equipment, utilities and cleanrooms
All GMP-critical equipment, utilities and cleanrooms are qualified, following a plan that sets scope and responsibilities. Qualification runs as a separate stream in parallel with construction, and the acceptance criteria are fixed before equipment is ordered.
Stage 4
Validate process and systems
Process, control and production systems are validated, with the scope set by risk. Critical process parameters and acceptance criteria are set before the first run, and the number of validation batches is justified on a risk basis.
Stage 5
Reach inspection readiness
At the end stands a prioritized action plan up to the inspection, based on a review of documentation, open CAPAs, data integrity, training status and premises. A mock inspection shows beforehand where answers become uncertain under time pressure.
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An Entourage project manager runs the plan, the schedule and escalation and reports to a steering committee.
Frequently asked questions
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