Qualification
DQ, IQ, OQ and PQ explained
DQ, IQ, OQ and PQ explained: objectives, test points and evidence for each qualification stage, with practical examples from cleanrooms, HVAC and compressed air.
· 9 min read
Service 01
Qualification
DQ, IQ, OQ and PQ for cleanrooms, HVAC systems, compressed air, pharmaceutical water and process equipment. We derive the test scope from the risk assessment.
What it is about
Qualification demonstrates that facilities, systems and equipment are fit for their intended use. Annex 15 of the EU GMP Guide requires it, and 21 CFR Part 211 sets comparable requirements for buildings and equipment. We start with the qualification master plan and the risk assessment. Together they determine which object is tested and to what depth. Test plans contain acceptance criteria that are approved before testing. We record deviations with an assessment and an action. The result is a report your quality unit can approve.
Scope based on risk
An aseptic area gets the full scope. For a non-classified room, complete documentation comes first. The justification is in the risk assessment.
Criteria before testing
Every test item has an acceptance criterion with a traceable origin: from the DQ, the URS or a standard.
Deviations closed out
Critical deviations are closed before the report is approved. Non-critical ones are assessed and tracked with a due date and an owner.
Approach
How we work together.
- 01
QMP and risk
Define objects, scope per object and responsibilities. Assess risks to product and patient.
- 02
Test plans
Define test items, methods and acceptance criteria and have them approved in advance.
- 03
Execution
Perform or witness tests, record expected and actual values, secure raw data and evidence.
- 04
Report and approval
Evaluate results, close deviations, prepare approval and qualification status.
The qualification chain
- 01
QMP
Define objects, interfaces and scope
- 02
Risk assessment
shows what is critical for product and patient
- 03
URS
GMP-relevant requirements only
- 04
DQ
User requirements against supplier specification
- 05
IQ · OQ · PQ
Expected against actual, with evidence
- 06
Approval
Report, then requalification
Sample documents
Structure and level of detail by example.
Unique IDs, acceptance criteria before testing, approval fields and consistent references.
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Risk matrix Sample -
Traceability matrix Sample -
OQ test protocol Sample
All documents shown are fictitious samples in the X-Mon document design. They show layout and structure and contain no customer data and no extracts from regulations. Click to enlarge.
Questions
Frequently asked questions.
Do you carry out the tests yourselves?
That depends on the project. We write plans and protocols, carry out or witness tests and write the reports. Whether a specialist contractor takes on individual measurements is clearly defined in our quotation.
How do room and HVAC qualification relate?
They are two qualification objects. Where one ends and the other begins is defined as an interface in the qualification plan, for example whether terminal HEPA filters and room pressure sensors belong to the HVAC system or to the room. A room also has its own OQ, for example for airlock door interlocks and airlock indicators. In the OQ both come together: pressure cascade, airflow direction, cleanliness grade and recovery time can only be demonstrated in the finished room with the system running. Which protocol these tests belong to follows from the interface.
Do you carry out temperature mapping yourselves?
Yes. We write the plan and protocol, place our calibrated data loggers at risk-based measuring points, evaluate the data and write the report, including a recommendation on where the permanent monitoring sensors belong. Where storage areas are part of a room that is qualified anyway, mapping is part of the room or HVAC qualification. We do not map transport routes.
Can you take over a qualification that is already under way?
Yes. We start with a short review of the current status: what is complete, what is open and where evidence or the link to a requirement is missing.
What about requalification?
That is included. After a change, the risk assessment shows which tests are needed. For the periodic review we look at calibration trends, maintenance, deviations and the sum of small changes.
Insights
Related articles.
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Contact
Qualification: tell us about your project.
You will get a personal reply with a first assessment of scope and approach.