PROTOCOLREFERENCE OUTLINE

Equipment Qualification Protocol (IQ/OQ/PQ)

A combined installation, operational, and performance qualification protocol with pre-approved acceptance criteria, a requirements-to-test traceability table, and a deviation-handling section — the URS→DQ→IQ→OQ→PQ flow expected by EU GMP Annex 15, sized to system impact per ASTM E2500.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
EU GMP Annex 15ASTM E2500ICH Q9(R1)
DOCUMENT TYPE
Protocol
LAST UPDATED
August 2026
PURPOSE

The protocol that establishes, before execution, what a system must do and what evidence will prove it does — then records that evidence once, in a sequence a reviewer can follow. The usual failure is acceptance criteria written after the test result is known, or a traceability table that lists requirements without showing which test verified each one. Depth of verification is a determination the organisation owns, sized to impact.

What's Inside

✓System description and impact assessment, stating the boundary so the protocol covers one system completely
✓Requirements-to-test traceability table proving every requirement has a test and every test has a requirement
✓Installation qualification checks against the as-built documentation set, with the revision of each drawing recorded
✓Operational qualification tests and challenges at the limits, not only at the comfortable nominal setpoint
✓Performance qualification run under representative loading, with acceptance criteria approved before any result is generated
✓Deviation handling defined in advance, so an unexpected result is dispositioned rather than quietly re-tested
✓Qualification conclusion and release, separating the test outcome from the decision to put the system into use

How to Use It

1Confirm the user requirements and the system’s impact classification first; verification depth follows from impact, and cannot be decided afterwards
2Pre-approve the protocol and every acceptance criterion before execution begins — criteria written after a result are not acceptance criteria
3Complete the traceability table before testing, and use it to find requirements no test covers while changes are still cheap
4Execute installation, then operational, then performance qualification, recording actual results rather than ticks; a tick proves nothing was read
5Disposition every deviation against the pre-defined handling route before closure, including those resolved by re-test, and record the justification
6Summarise the qualified state, list the conditions it depends on, and release the system only when quality has approved that summary
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1System Description and Approach
2Requirements Traceability
3IQ / OQ / PQ Tests
› Installation qualification (IQ)› Operational qualification (OQ)› Performance qualification (PQ)
4Deviation Handling and Conclusion
REGULATORY CONTEXT

EU GMP Annex 15 sets the qualification lifecycle and expects acceptance criteria to be approved before execution; ASTM E2500 supports sizing verification to system impact rather than testing everything equally; ICH Q9(R1) supplies the risk basis for that sizing. None of the three tells you which attributes of your system are critical, how many runs constitute performance qualification, or when a deviation is significant. Those determinations belong to your organisation, and this protocol is structured to make you record them.

MAPPED STANDARDS
EU GMP Annex 15ASTM E2500ICH Q9(R1)
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