Qualifying new pharmaceutical production equipment
POMEX’s work at a pharmaceutical production site.
New equipment can only produce once it has been proven to be correctly installed and to work reproducibly.
Our client had to qualify a new machine within its project deadlines.
01. Context and challenges
The project challenges:
- equipment critical to production, expected on a fixed date;
- several stakeholders: production, quality, maintenance and the supplier;
- GMP and computerised system validation requirements to meet;
- a file that had to stand up to an inspection.
02. Our approach
POMEX managed the entire qualification process:
- writing the user requirements specification (URS) with the departments, ranking requirements by criticality;
- risk analysis (FMEA) to target the tests;
- FAT at the supplier, then SAT on site, tracking each deviation until it was resolved;
- installation, operational and performance qualification (IQ, OQ, PQ);
- computerised system validation in line with Annex 11 and 21 CFR Part 11.
03. Results
A qualification plan approved from the start guided all parties. The result:
- equipment qualified and in production within the project deadlines;
- a complete and consistent file, ready for inspection;
- deviations resolved before start-up;
- critical parameters identified for routine monitoring.
Conclusion
A well-run qualification does not delay a project: it secures its start-up.
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