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EQUIPMENT & PROCESS QUALIFICATION

IQ, OQ & PQ Qualification

We structure installation, operating-range, and performance evidence with deviation and retest criteria.

RECOMMENDED FOROperations teams that need documented fitness and repeatable performance before using equipment, systems, or processes

SCOPE OF WORK

Scope of work

Before contracting, we confirm the current state and responsibility boundary, then fix only the necessary work in scope.

01

Verify installation environment, components, utilities, calibration, and safety

02

Test operating ranges, alarms, interlocks, and worst-case conditions

03

Confirm performance using actual materials, operators, and lot conditions

04

Control deviations, retests, conditional acceptance, and approvals

KEY DELIVERABLES

Evidence that remains

We prioritize the connection between requirements, execution, results, and approval over document names.

01IQ protocol and results
02OQ protocol and results
03PQ protocol and results
04Deviation and final conclusion report

WORKFLOW

Workflow

We review each stage before moving forward and retain unresolved items in a controlled action register.

  1. 01

    Check criteria and state

    Compare URS, risks, vendor documentation, and the installed state.

  2. 02

    IQ

    Verify installation, configuration, required records, calibration, and safety.

  3. 03

    OQ

    Verify operating ranges, controls, alarms, and worst-case behavior.

  4. 04

    PQ

    Confirm repeatability and performance under actual use conditions.

RESPONSIBILITY BOUNDARY

Conditions and responsibility boundary

IQ, OQ, and PQ are not document packages alone. Completion requires the actual state, raw data, review, and approval records.

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EQUIPMENT ACCEPTANCE

Evidence must connect requirements to operation

A supplier test result does not by itself establish fitness for the user's process. We compare it with intended use, contractual requirements, site conditions, raw records and open issues.

  1. 01

    Agree the baseline

    Approve intended use, contractual specifications, URS and test criteria first

  2. 02

    Factory FAT

    Check functions, safety tests and source records at the supplier site

  3. 03

    Site SAT · IQ/OQ

    Recheck transport, installation, utilities and operating range

  4. 04

    Acceptance advice

    Trace requirements, tests, deviations and retests to a supported opinion

  5. 05

    Maintain control

    Track service, calibration, changes and process PQ where justified

Separate responsibilities, connect evidence

Equipment supplier

Provide final specifications, drawings, test records and corrections

Independent reviewer

Compare documents and site results; identify open risks and advise

User organization

Approve intended use and criteria in advance; make the final acceptance decision

Requirement ID → approved protocol → raw evidence → deviation/retest → review opinion → final decision

IQ/OQ/PQ is not complete merely because documents exist. Execution records and approvals matter. A private review opinion is not an official GMP certificate.