Who can perform the qualification of a GMP instrument (and how much it costs)

Who is entitled to perform the qualification

There is no single "license" for qualifying in GMP. What counts is demonstrable competence and working according to documented procedures. In practice qualification is performed by:

• the site's internal personnel (metrology, engineering, validation), when it has sufficient resources and competencies;
• a specialized service provider, which brings method, reference instrumentation and peak capacity, while the site retains approval and responsibility;
• a mix of the two: the supplier performs the field activities (protocol execution, smoke study, periodic requalifications), the site drafts/approves and integrates it into its own quality system.

In all cases, the GMP responsibility remains with the MA holder / the site: it can delegate the execution, not the responsibility.

What to ask a qualification supplier in Italy

If you are evaluating a company for IQ/OQ/PQ qualification services, these are useful questions:

1. References in the regulated pharmaceutical context (not just generic industry): GMP qualification has specific documentary requirements.
2. Documented operating procedures and the ability to work on your SOPs when required.
3. Reference instrumentation with traceability guaranteed through ACCREDIA-accredited laboratories, with certificates in their period of validity.
4. Competence on computerized systems (Annex 11, GAMP5) if the equipment includes software.
5. Management of deviations during the execution of protocols, not just the filling in of forms.
6. The ability to integrate qualification, calibration and change control, so as to avoid fragmentation across different suppliers.

What the cost depends on

The cost of a qualification does not come down to a per-instrument rate. It depends on:

• complexity of the equipment (a balance vs an autoclave vs an HVAC system);
• number and depth of the protocols (full IQ/OQ/PQ vs combined IQ/OQ);
• presence of a computerized system to validate;
• number of measuring instruments involved and their calibrations;
• periodic requalifications and their frequency;
• starting documentary status (URS and specifications already available or to be drafted).

For this reason a serious quotation is born from an assessment of the equipment and of the GMP objective, not from a single-line price list. A supplier that throws out a price without having understood the criticality of the equipment usually has not understood the qualification either.

Why Eurosystem

Eurosystem has operated since 1990 in regulated pharmaceutical sites and offers qualification and validation services — execution of IQ/OQ/PQ protocols, AFP smoke studies, thermal requalifications, change control support — with reference instrumentation traceable through ACCREDIA-accredited laboratories. The advantage is the integration: qualification, calibration (the Dimacs platform, over 11,000 instruments), automation and access control under a single partner that knows regulated environments from the inside. For an assessment, contact us.