Commissioning & Qualification (C&Q)

Commissioning and qualification prove that a facility, utility or piece of equipment is installed correctly and performs as intended. PharmExpert plans and executes risk-based C&Q aligned to ASTM E2500 and EU GMP Annex 15, leveraging good engineering practice and focusing qualification effort on what genuinely affects product quality — not exhaustive documentation of low-risk attributes.

The risk-based approach matters. Traditional C&Q too often re-tests vendor-standard functionality at length while adding little assurance. We use commissioning and supplier evidence where appropriate, then concentrate qualification on the critical aspects, producing a leaner, more defensible package that still satisfies inspectors.

We cover the full scope: cleanroom and HVAC qualification — classification, recovery, pressure cascades and airflow visualization (smoke studies) for at-rest and dynamic conditions; utility qualification for water (PW/WFI), compressed gases and clean steam, including phased water-system sampling; and equipment IQ/OQ/PQ.

Where FAT audits have already verified equipment at the vendor, that evidence is leveraged to streamline on-site qualification. We author and execute the protocols, and establish the requalification and routine-monitoring strategy that keeps systems demonstrably in control — particularly important for sites aligning to the revised Annex 1.