From the URS through DQ, IQ, OQ and PQ to requalification: risk-based to EU GMP Annex 15 and ICH Q9, documented so it holds up in an audit. From Visp in the Valais, on site in running GMP operations across Switzerland.
Qualification demonstrates that facilities, systems and equipment are fit for their purpose; validation, that processes reproducibly deliver the required quality. Our field:
Every service ends with an audit-proof document, not a recommendation. What you actually receive:
We write requirements that are testable, unambiguous and atomic, and flag the GMP-critical ones. Every later stage is tested against this URS.
Outcome: a URS that holds up in an audit, with a traceability matrix.
We plan and execute the four stages on a risk basis: acceptance criteria before testing, test depth by criticality, deviations assessed and closed.
Outcome: executed protocols and reports that carry the release.
Following ASTM E2500 and Annex 15, we recognise robust commissioning evidence from FAT and SAT for qualification instead of repeating it.
Outcome: leveraging with a documented rationale, less duplicated work.
Classification to ISO 14644, recovery times, airflow visualisation, water systems in three phases: the media on which product quality depends.
Outcome: classified, monitored systems with a robust monitoring concept.
From the critical process parameters through PPQ to Continued Process Verification: the proof that is continually renewed.
Outcome: a demonstrably controlled process, not just three good batches.
We derive frequency and scope from risk, not from the calendar, supported by change control, monitoring trends and the periodic review.
Outcome: a requalification concept that directs effort to where it creates assurance.
Sharpen the URS, assess GMP impact, set the test depth on a risk basis.
Stages, responsibilities, acceptance criteria and leveraging strategy, aligned with your QA.
Write and execute the protocols, assess and close deviations, traceable without gaps.
Qualification report with an assessment of all deviations as the basis for release.
Change control, periodic review and risk-based requalification maintain the state.
Our engineers work in GMP cleanroom operations, not just at the desk. Test points fit the real facility and the real interventions.
Vispact is based in Visp, at the heart of the Swiss life-science industry. Short distances in the Valais, assignments across Switzerland and Germany.
Test depth is a risk decision. We test what protects product and patient, and justify in documented form what we leave out.
Every requirement is traceable through to its test evidence. That is the standard we hold ourselves to.
Qualification refers to facilities, systems and equipment: the evidence that the equipment is fit for its purpose. Validation refers to processes and methods: the evidence that they reproducibly deliver the required quality. Both follow the risk-based logic of EU GMP Annex 15.
Design Qualification: the intended design meets the requirements from the URS. Installation Qualification: delivered and installed as specified. Operational Qualification: function demonstrated across the entire operating range. Performance Qualification: performance is reproducible under real conditions.
No. Annex 15 deliberately names no rigid interval, but requires a justified, risk-based determination. Frequency and scope follow from GMP impact, stability in operation and the significance of ongoing monitoring.
Yes, Annex 15 and ASTM E2500 permit leveraging robust commissioning evidence, provided it was produced in line with Good Engineering Practice: calibrated test equipment, acceptance criteria before testing, referenceable documentation. Repetition in IQ or OQ then becomes unnecessary.
With a 30-minute initial conversation, no strings attached. A criticality assessment of your systems follows, from which test depth and a sound plan emerge. Reply within one working day, straight from engineering.
In the initial conversation we place your starting point: 30 minutes, no strings attached. Reply within one working day, straight from engineering.
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