How do life sciences companies combine CAPEX planning for production facilities with a qualification that holds up in front of an inspector?

In a CAPEX project for a regulated production facility, the most expensive commitments are made before the first machine is ordered. The User Requirement Specification comes first, because under EU-GMP Annex 15 it is the starting point of qualification: whatever is not stated there cannot be demonstrated later in DQ, IQ, OQ and PQ.

Only once the URS fully captures the GMP requirements from the EU GMP Guide (Eudralex Volume 4) and, for sterile processes, from Annex 1 does the tender provide a benchmark against which bids can be compared and suppliers contractually bound.

Reversing this sequence and awarding the contract first shifts the clarification into the construction phase, where every correction runs through change orders.

Things get critical a second time at the transition from the supplier to the company's own site. A Factory Acceptance Test verifies against the URS before the facility is delivered; the Site Acceptance Test and the subsequent qualification under Annex 15 turn this into the documented evidence for GMP-compliant commissioning.

Defects identified in the FAT are cheap to resolve at the supplier, the same defects at the final site delay commissioning.

Precisely for this reason the qualification plan belongs in the early planning and not at the end of the project, and precisely for this reason we review the regulatory consequences of a new facility or a new site already in the business case, before capital is committed.