IQ/OQ Qualification
We perform IQ/OQ qualification (Installation Qualification and Operational Qualification) for particle counters, air samplers and cleanroom equipment. The documentation ensures that your instruments meet GMP requirements.
What is IQ/OQ qualification?
In short: IQ (Installation Qualification) verifies that equipment is correctly installed. OQ (Operational Qualification) verifies that equipment operates according to specification. Together, they document that your equipment is qualified for its intended purpose.
Why is IQ/OQ needed?
In short: IQ/OQ is required by GMP regulations and EU GMP Annex 1 for equipment in regulated environments. It ensures that your measurement instruments and cleanroom systems operate reliably and provides documentation for audits.
What is included in the qualification?
In short: Verification of installation, functional testing, documentation of all steps, protocol with pass/fail assessment and a complete qualification report.
How long does an IQ/OQ take?
In short: The time required depends on the type and number of equipment units. A single particle counter normally takes one to two days. Larger installations are planned individually.
When is this relevant?
- New installation of particle counters or air samplers
- New cleanroom or cleanroom upgrade
- GMP requirement for qualified equipment
- Before regulatory inspections or audits
- After relocation or reinstallation of equipment
- Periodic requalification
What is included
- Development of qualification protocol
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Complete qualification report
- Deviation reporting as needed
- Advice on qualification intervals
How it works
Contact
Describe your equipment and qualification needs. We propose an appropriate scope.
Protocol
We develop an IQ/OQ protocol tailored to your equipment and regulatory requirements.
Execution
The qualification is carried out on-site with complete documentation of every step.
Report
You receive a complete qualification report with all protocols and results.
Follow-up
We help you plan ongoing requalification and provide support during audits.
What you receive
- IQ protocol with verification
- OQ protocol with functional testing
- Complete qualification report
- Deviation reports as needed
- Documentation for GMP audit
Industries we serve
Hospitals & Clinics
Air sampling in operating theatres, sterilisation units and cleanroom environmen...
Pharmaceuticals & Biotech
Microbiological air monitoring in cleanrooms, aseptic production and sterility t...
Food & QC
Monitor air quality in food production lines. Microbiological monitoring and par...
Equipment
Related instruments
We sell and calibrate instruments used for this type of sampling.
Frequently asked questions about iq/oq
IQ verifies installation, OQ verifies function, and PQ (Performance Qualification) verifies that the equipment delivers in actual production. We offer IQ and OQ.
Yes, we can perform IQ/OQ on most particle counters and air samplers regardless of brand.
The requalification interval depends on your risk assessment and regulatory requirements. Every two to three years is common, or after major changes.
Yes, our qualification protocols are designed to meet the requirements of EU GMP Annex 1 and ISPE GAMP 5.
Yes, we can combine IQ/OQ with calibration to minimise downtime and costs.
Contact
Book a free assessment
Describe your situation and we will carry out an assessment and get back to you with a proposal and quote.
What happens next?
Quick response
We get back to you within 1 business day
3-5 questions
We ask questions to find the right approach
Proposal + quote
You receive a tailored proposal
Get a Quote Within 48 Hours
Tell us about your facility and requirements — we'll respond with a detailed proposal within two business days.