Equipment Qualification (IQ/OQ/PQ) Checklist Template

Owned by the validation lead, as soon as the equipment is needed. Enter the target release date on the first task: every due date counts back from it in working days, and the handover counts forward. Write the user requirement specification and get QA’s approval of it, then choose the supplier and say whether the design is new or a standard item.

• Record the equipment and the qualification team — the equipment and its asset number, where it will be installed, what it will be used for, the target release date that every due date counts from, the validation lead, the system owner, the engineering lead and the QA approver
• Write the user requirement specification (URS) — what the equipment must do and the conditions it must meet: its intended use, capacity and operating ranges, product-contact materials, cleaning, utilities, controls and data, safety, and the documents the supplier must provide
• QA approves the URS — the system owner has confirmed it describes the intended use, and QA approves it as the reference for the whole qualification
• Choose the supplier and the model against the URS — the supplier, model and options that meet the URS, and whether the design is new, customised or modified, or a standard catalogue item used as designed
• Agree the supplier’s documents and tests in the order — the drawings, material certificates, calibration certificates, manuals and the factory acceptance test the supplier will provide, and which of them your qualification will rely on

Owned by the validation lead with the engineering lead. The risk assessment decides which functions and parameters are critical and how much testing each needs. A new, customised or modified design gets a design qualification; a standard item used as designed gets a recorded check of the supplier’s design against the URS instead (the answer on the supplier task in Phase 1).

• Assess the risks to product quality — which functions, parameters and parts of the equipment could affect product quality, how each could fail and how serious that would be, and how much testing each needs; the scope of the qualification follows from it
• Check the design against the URS — the drawings, specifications, materials and control design reviewed against every URS requirement, including GMP points such as cleanability and product-contact materials
• QA approves the design qualification — the design qualification report, with every requirement the design does not meet resolved or accepted with a reason
• Check the standard design against the URS — the supplier’s published specification and options checked against every URS requirement, with the reason no design qualification protocol is needed, taken from the risk assessment
• Start the requirements trace matrix — each URS requirement against the test that will verify it: the design check, the FAT, the SAT, IQ, OQ or PQ

Owned by the validation lead, approved by QA. The plan says which tests are run where, which FAT or SAT results are relied on and where performance qualification is done; its answers add the FAT and SAT tasks and decide where PQ appears. No IQ or OQ test is run before QA approves the protocols at the end of this phase.

• Write the validation plan — the scope, the qualification stages and their order, the tests and how acceptance criteria are set, which FAT or SAT results are relied on, where PQ is done, who does what, and how deviations and changes are handled
• QA approves the validation plan — QA reviews and approves the plan before the protocols are written to it
• Write the IQ protocol — the installation checks against drawings and specifications, the materials of construction, the documents to collect and the instruments to calibrate, each with its acceptance criterion
• Write the OQ protocol — the functional tests, alarms and interlocks, and tests at the upper and lower operating limits or worst case, each with its acceptance criterion; add the PQ tests here when PQ is combined with OQ
• Check any protocols written by the supplier or a contractor — each one checked for suitability and against your own procedures before approval, with extra tests added where it falls short
• QA approves the IQ and OQ protocols — QA approves each protocol before any test in it is run

Owned by the engineering lead. The FAT itself has its own checklist; here you check the FAT results the protocols rely on, receive and install the equipment and, where the plan relies on one, witness the site acceptance test. The FAT and SAT tasks appear from the answer on the validation plan task.

• Check the FAT results the protocols rely on — the FAT report, its deviations and how each was closed, and evidence that transport and installation do not affect the functions tested, for every FAT test that IQ or OQ will not repeat
• Receive and inspect the equipment — checked against the order on arrival: damage, parts and options, serial numbers and the supplier’s documents
• Install and connect the equipment — installed in its room by the supplier or your engineers, with utilities connected and start-up checks done, ready for site testing and IQ
• Witness the site acceptance test and review its report — the SAT run at your site to the agreed plan, its results and deviations recorded, and the tests IQ and OQ will rely on marked in the trace matrix

Owned by the validation lead, run to the IQ protocol QA approved in Phase 3. IQ shows the equipment is installed as designed. Record every result that misses its acceptance criterion as a deviation at once, in the log in Phase 8, answer Yes to the deviation question there, and tell QA. QA releases IQ to OQ at the end of the phase.

• Verify the installation against the drawings and specifications — components, instruments, pipework, wiring and services checked against the engineering drawings, the specifications and the protocol’s criteria
• Verify the materials of construction — product-contact materials and finishes checked against the URS and the certificates supplied
• Collect the supplier’s operating and maintenance instructions — manuals, maintenance requirements, spare parts lists and as-built drawings filed in the qualification file
• Calibrate the critical instruments — each instrument the risk assessment marks critical calibrated, with a traceable certificate, before OQ relies on its readings
• QA reviews IQ and releases it to OQ — the executed IQ reviewed, every deviation closed or assessed as having no significant impact on OQ (investigated on the deviation tasks in Phase 8, which appear once a deviation is logged), and OQ released to start

Owned by the validation lead, run to the OQ protocol QA approved, once QA has released IQ. OQ shows the equipment works as intended across its operating ranges, including its limits. A successful OQ lets the operating, cleaning and maintenance procedures be finalised and the operators trained.

• Run the functional tests — controls, sequences, alarms, interlocks and safety functions tested to the OQ protocol, with the results recorded at the time
• Test the upper and lower operating limits and worst case — each critical parameter run at its upper and lower limits, or under the worst-case conditions the protocol defines
• Finalise the operating, cleaning and maintenance procedures — the operating procedure, the cleaning procedure and the preventive maintenance plan written from what OQ showed, then approved
• Train the operators — the people who will run, clean and maintain the equipment trained on the new procedures, with training records kept
• Run the PQ tests in the combined OQ and PQ protocol — the performance tests with production materials, qualified substitutes or simulated product under normal operating conditions, as the combined protocol sets out
• QA reviews OQ and releases the next stage — the executed OQ reviewed, every deviation closed or assessed (investigated on the deviation tasks in Phase 8, which appear once a deviation is logged), and the next stage released: PQ, or the summary report when PQ was combined with OQ or is done within process validation
• Agree how process validation completes PQ — the process validation protocol that will show the equipment performs effectively and reproducibly, the batches it covers, and the condition on release that the equipment is used only for those batches until the process validation report is approved

Applies only when PQ is a separate protocol after OQ (the answer on the validation plan task in Phase 3). PQ shows the equipment performs effectively and reproducibly with the approved process and product, under normal operating conditions. QA approves the PQ protocol before any PQ run.

• Write the PQ protocol — the PQ tests with production materials, qualified substitutes or simulated product under normal operating conditions, worst-case batch sizes, the sampling frequency with its justification, and the acceptance criteria
• QA approves the PQ protocol — QA approves the protocol before any PQ run
• Run the PQ — the runs the protocol sets out, across the operating range of the intended process, by trained operators using the approved procedures
• Review the PQ results against the acceptance criteria — every result compared with its criterion, a deviation raised for any that misses, and the conclusion recorded

Owned by the validation lead, with QA. Every deviation is investigated and closed or assessed, every URS requirement is traced to a passed test and the summary report gives a recommendation. QA alone decides on release, and the checklist halts there: nothing in Phase 9 can be completed until the decision is recorded.

• Collect every deviation and protocol change — every result that missed its acceptance criterion and every significant change to an approved protocol during testing, each logged as a deviation as it happens, in IQ, OQ or PQ
• Investigate each deviation and its impact — the cause, the effect on the result and on the qualification, and whether earlier stages or other equipment are affected; start as soon as a deviation is logged, so it is assessed before QA releases that stage
• Correct, retest and record each deviation — the correction or corrective action, any retest under the protocol, and the scientific justification for any acceptance criterion that changed
• QA closes each deviation — each deviation closed, or left open with a documented assessment of its impact for the release decision
• Complete the requirements trace matrix — every URS requirement traced to a test that passed, or to a deviation that is closed or assessed
• Write the qualification summary report — the results summarised against the acceptance criteria, the deviations and their outcome, any changed criteria with their justification, and a recommendation on release
• Put right what stopped the release — after Not released only: what QA objected to, the work, retests or documents needed, and a new target release date on the first task if it has to move
• QA releases the equipment for use — Released for use, Released with conditions or Not released, with the reasons, recorded by the QA approver alone after reviewing the summary report

Applies only when the equipment has been released: a Not released decision in Phase 8 hides this phase until a new decision is recorded. The equipment goes under change control, into the calibration, maintenance and cleaning schedules and onto the periodic review schedule, and the qualification file is archived.

• Update the equipment’s status and logbook — the status label, the equipment logbook and the site’s list of qualified equipment show it as released, with any condition
• Put the equipment under change control — any change to the equipment, its software, its parts or its procedures from now on goes through change control, which assesses the effect on the qualified state and plans any requalification
• Add it to the calibration, maintenance and cleaning schedules — its critical instruments into the calibration programme, and its preventive maintenance and cleaning into their schedules, so the qualified state is kept
• Meet the release conditions — each condition QA set, met and recorded, such as an open deviation closed or the process validation report approved
• Set the periodic review date — when the equipment will next be evaluated to confirm it remains in a state of control, with the period justified and the criteria defined
• Archive the qualification file — the URS, risk assessment, design records, plan, approved and executed protocols, deviations, trace matrix, report and release, filed where they can be retrieved