This is a ready-to-use audit checklist for a site’s equipment and instrument qualification program as a whole, not a single asset’s execution protocol. Use it to run a self-audit, to take over an inherited program, or to assess a contract site before you rely on its equipment. Mark each item Pass, Fail, or N/A, note the evidence you actually checked, and record findings as you go. Replace every <<FILL: ...>> placeholder with your own specifics. A filled specimen follows the blank checklist. This is educational reference content, not legal or regulatory advice; verify every cited regulation against its current published version before you rely on it.
For the narrative behind every item here, the method for running the audit in order, and the severity logic this checklist scores against, see Equipment and Instrument Qualification Audit Checklist.
Header
| Field | Entry |
|---|---|
| Checklist number | <<FILL: AUD-ID>> |
| Site / facility | <<FILL>> |
| Audit type | <<FILL: self-audit / internal audit / CMO oversight / pre-inspection readiness>> |
| Auditor(s) | <<FILL>> |
| Audit date(s) | <<FILL>> |
| Equipment master list (EML) population | <<FILL: total GxP asset count>> |
| Sample size and technique | <<FILL: count and rationale, e.g. "8 assets, stratified random across risk classes">> |
| Assets sampled (IDs) | <<FILL: list>> |
Section 0: Equipment Master List and Inventory
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 0.1 | A complete, current equipment master list exists and was produced before the sample was drawn | 21 CFR 211.182; EU GMP Ch. 3 | EML export, date-stamped | ||
| 0.2 | EML fields include ID, description, location, criticality, calibration requirement, qualification status, last qualified date, next periodic review date, doc location, PM/cal owner | EML column headers | |||
| 0.3 | Five assets picked at random from the floor are found on the EML with matching ID labels | Floor walk vs EML | |||
| 0.4 | Sorting the EML by “last qualified” surfaces no direct-impact asset qualified more than the site’s own periodic review interval ago with no review on file | EU GMP Annex 15 (2015) | Sorted EML | ||
| 0.5 | Retired equipment is flagged as retired on the EML and is confirmed physically disconnected or removed, not just relabeled | Floor walk, decommissioning record |
Section 1: Classification and Framework Alignment
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 1.1 | Each sampled asset has a documented direct-impact / not-direct-impact classification with rationale | ISPE C&Q Baseline Guide, Vol. 5 | Impact assessment record | ||
| 1.2 | For a not-direct-impact asset, commissioning (not formal qualification) is the documented approach, and that decision predates the work | Commissioning record | |||
| 1.3 | Each sampled analytical instrument has a documented USP <1058> Group A/B/C classification with rationale | USP <1058> | Classification record | ||
| 1.4 | The classification matches the qualification depth actually performed (no Group C instrument qualified to Group B depth) | USP <1058> | Compare classification to executed package | ||
| 1.5 | For a computerized instrument or automated equipment control layer, a GAMP category has been assigned to the software/automation element | GAMP 5 (2nd ed.) | Category assignment record | ||
| 1.6 | Calibration requirement and frequency are documented and justified for the instrument’s actual intended use, not copied from a vendor default | Calibration plan / basis record |
Section 2: Design Qualification (DQ)
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 2.1 | An approved URS exists for the asset | EU GMP Annex 15 (2015) | URS document | ||
| 2.2 | URS requirements are specific to GxP use, not generic vendor specifications | URS content | |||
| 2.3 | Vendor documentation was formally reviewed against the URS, with reviewer and date | DQ record | |||
| 2.4 | Gaps between vendor spec and URS are documented and resolved before procurement or go-live | DQ record, gap log | |||
| 2.5 | A traceability line exists from at least three sampled URS requirements to where each is verified in IQ/OQ/PQ | Traceability matrix or manual trace |
Section 3: Installation Qualification (IQ)
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 3.1 | IQ protocol was approved before execution (approval date predates execution dates) | Protocol approval page vs execution dates | |||
| 3.2 | Acceptance criteria are specific, not “verify installed correctly” | Protocol criteria | |||
| 3.3 | Execution records show every step performed with results recorded at the time, not reconstructed | Execution record | |||
| 3.4 | Identity, utilities, safety systems, and installation conditions are verified against the URS/DQ | Execution record | |||
| 3.5 | Software/firmware version is recorded for computerized instruments | Execution record | |||
| 3.6 | Every test instrument or reference standard used during IQ/OQ was itself in calibration, with certificate IDs recorded | Execution record, cal certs |
Section 4: Operational Qualification (OQ)
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 4.1 | OQ protocol approved after IQ completion, with specific numeric acceptance criteria | Protocol | |||
| 4.2 | Testing covers the full intended operating range, including edge/worst-case conditions, not one comfortable point | Execution record | |||
| 4.3 | Results are recorded as actual measured values, not pass/fail ticks only | Execution record | |||
| 4.4 | For computerized instruments, software functions (audit trail, access control, e-signatures, calculations) are tested | Execution record | |||
| 4.5 | Alarms and interlocks are challenged at setpoint and at the alarm limit, where applicable | Execution record | |||
| 4.6 | Deviations are documented, investigated, and dispositioned before OQ is closed and the report approved | Deviation record, OQ report |
Section 5: Performance Qualification (PQ)
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 5.1 | PQ protocol approved and executed after OQ acceptance | Protocol, OQ report | |||
| 5.2 | PQ uses actual product/materials or a justified representative surrogate | Execution record | |||
| 5.3 | PQ is performed by actual users, not only the validation team | Execution record | |||
| 5.4 | PQ demonstrates reproducibility across multiple runs, not a single run | Execution record | |||
| 5.5 | Where PQ is folded into ongoing system suitability or method validation instead of a standalone protocol, that approach is documented and justified | Program documentation |
Section 6: Calibration
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 6.1 | Calibration performed at the documented frequency within its tolerance window | 21 CFR 211.68(a) | Calibration log | ||
| 6.2 | Calibration is traceable to a national metrology standard, with the traceability chain demonstrable on request | Calibration certificate | |||
| 6.3 | As-found and as-left readings are captured for every calibration event | Calibration record | |||
| 6.4 | A documented, followed process assesses backward impact on GxP data when an instrument fails calibration or is found out of tolerance | OOT investigation record | |||
| 6.5 | Instruments with expired or failed calibration are labeled and physically removed from GxP service | Floor walk, quarantine log | |||
| 6.6 | Certificates state the standards used and the measurement uncertainty | Calibration certificate |
Section 7: Maintenance
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 7.1 | A preventive maintenance (PM) schedule exists for the asset and PMs are performed on schedule | 21 CFR 211.68(a) | PM log | ||
| 7.2 | Worn parts or degraded performance found during PM trigger a documented impact assessment | PM record, impact assessment | |||
| 7.3 | Emergency repairs are assessed for qualification impact, with requalification performed before GxP use resumes where warranted | Repair ticket, change record | |||
| 7.4 | The equipment use and cleaning log required by 21 CFR 211.182 is current and complete | 21 CFR 211.182 | Use/cleaning log |
Section 8: Periodic Review and Requalification
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 8.1 | A periodic review schedule exists and the last three reviews for this asset occurred on schedule | EU GMP Annex 15 (2015) | Periodic review records | ||
| 8.2 | The review covers calibration status, repairs since the last review, software/firmware version, and recent performance trends | Periodic review record | |||
| 8.3 | The review concludes with a dated, named fitness-for-purpose statement | Periodic review record | |||
| 8.4 | Gaps identified at review are opened as CAPAs and tracked to closure | CAPA log | |||
| 8.5 | Requalification triggers (major repair, software upgrade, relocation, changed use, OOT indicating degradation) are defined and were applied when they occurred for this asset | Change/requal records |
Section 9: Change Control
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 9.1 | Change control procedure explicitly covers qualified equipment | 21 CFR 211.68(b) | SOP | ||
| 9.2 | Repairs and modifications since qualification are found in change control, not only on maintenance tickets | Change log vs maintenance log, cross-check | |||
| 9.3 | Impact assessments specifically evaluate qualification impact, not only safety or cost | Change record | |||
| 9.4 | Requalification is completed before return to GxP use where the change affects a qualified parameter | Change record, requal record | |||
| 9.5 | Firmware/software upgrades, including vendor field-service updates, are routed through change control rather than applied silently | Change log, service tickets |
Section 10: Documentation Package Completeness (per sampled asset)
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 10.1 | URS, DQ, IQ protocol/report, OQ protocol/report, PQ protocol/report (where applicable) are all present | Full package | |||
| 10.2 | Current calibration certificate and most recent periodic review are on file | Package | |||
| 10.3 | Change log is complete and current | Package | |||
| 10.4 | Acceptance criteria throughout are specific and numeric, not vague phrases | Package | |||
| 10.5 | Execution records show actual values, not only pass/fail | Package | |||
| 10.6 | Records show contemporaneous signing (dates line up with when testing occurred), and performer/verifier are not the same person for critical steps | Package |
Section 11: Single-Use, Disposable, and Portable Equipment (where in scope)
| # | Item | Reference | Evidence to check | Pass/Fail/N/A | Finding / note |
|---|---|---|---|---|---|
| 11.1 | Single-use/disposable assemblies are qualified at the design/type level (extractables assessed against actual process conditions, sterilization/irradiation validated, integrity-test method qualified), not treated as needing per-unit DQ/IQ/OQ/PQ | ASTM E3051; USP <665>/<1665> | Design qualification record, extractables report | ||
| 11.2 | A live supplier change-notification mechanism exists and notifications are actually assessed for extractables/qualification impact | Change-notification log | |||
| 11.3 | Point-of-use verification (visual check, integrity test, certificate-of-conformance review) is performed and documented before the assembly touches product | Batch record, integrity test record | |||
| 11.4 | Portable/mobile equipment is qualified across its intended range of locations, or a defined trigger requires re-verification on relocation | Qualification record, relocation log | |||
| 11.5 | The EML tracks current location for mobile assets and a floor walk confirms the asset is where the system says it is | EML, floor walk |
Roles Verified
| # | Item | Pass/Fail/N/A | Finding / note |
|---|---|---|---|
| R.1 | Interview confirms a user and a metrology/engineering owner can each explain how they know the asset is fit to use today | ||
| R.2 | The handoff for who notifies Quality when a calibration fails or a PM finds a worn part is explicit and understood by both sides |
Severity Scoring
Score each Fail against the severity definitions below (full rationale in the source article).
| Severity | Definition |
|---|---|
| Critical | Equipment in GxP use without completed qualification, or required requalification not performed after a triggering event |
| Major | Qualification exists but has gaps that could affect data reliability |
| Minor | Organizational or completeness issues that do not affect the validity of specific GxP data |
| Item | Entry |
|---|---|
| Total items scored | <<FILL: count>> |
| Fails, Critical | <<FILL: count>> |
| Fails, Major | <<FILL: count>> |
| Fails, Minor | <<FILL: count>> |
| Overall program assessment | <<FILL: Audit-ready / Conditional, remediation required / Not ready>> |
Detailed findings with individual severity classification, impact assessment, and CAPA ownership belong in a separate audit findings report; see the paired “Equipment Qualification Audit Findings and Severity Summary” report template.
Sign-off
| Role | Name | Signature | Date |
|---|---|---|---|
| Auditor | <<FILL>> | ||
| Site quality reviewer | <<FILL>> |
Filled specimen
Representative subset of a completed audit at a mid-sized QC lab and manufacturing site (EML population 210 assets; sample of 7, stratified: 2 Group C analytical instruments, 2 direct-impact manufacturing units, 1 environmental chamber, 1 balance, 1 portable data logger).
| # | Item | Result | Note |
|---|---|---|---|
| 0.3 | Five random floor assets match EML | Pass | All five confirmed, labels legible |
| 0.4 | No direct-impact asset overdue on periodic review by EML sort | Fail (Major) | Bioreactor BRX-014 last qualified 2022-01, no periodic review on file |
| 1.4 | Classification matches depth performed | Fail (Major) | HPLC-11 classified Group C but audit trail function never tested in OQ |
| 3.6 | Test instruments used in IQ/OQ were themselves calibrated | Pass | All 4 reference thermocouples had current cal IDs recorded |
| 4.2 | OQ covers full range including edge conditions | Fail (Minor) | Balance BAL-0042 OQ tested only at 100 g and 200 g, not at the 5 mg low end actually used |
| 6.4 | Backward impact assessment on OOT | Pass | pH meter OOT in March triggered a documented data-window review, no impact found |
| 9.2 | Repairs found in change control | Fail (Critical) | BRX-014 impeller shaft replaced March 2026, no change record found, three batches run since with no requalification assessment |
| 11.4 | Portable equipment qualified across intended locations | Pass | Data logger DL-07 qualified across all 3 rooms it moves between, with a defined re-verification trigger on relocation to a fourth |
Severity scoring: 1 Critical (BRX-014 undocumented repair, no requalification assessment, batches run since), 2 Major (BRX-014 periodic review overdue; HPLC-11 audit trail never OQ-tested), 1 Minor (BAL-0042 OQ range). Overall program assessment: Conditional, remediation required before the next inspection window, driven by the Critical finding.
This specimen shows the checklist doing its job: the Critical finding traces from a single change-control cross-check (9.2), not from reading the bioreactor’s qualification binder in isolation, which is exactly the kind of gap a document-only review misses.
Common inspection findings this checklist prevents
- An audit that reviews qualification packages in isolation and never cross-checks the maintenance log against change control, missing undocumented repairs.
- A Group C instrument’s software and audit-trail functions never actually challenged because the audit stopped at “OQ report says pass.”
- A balance or chamber’s OQ range checked only at the comfortable middle, not at the edges actually used in routine work.
- Single-use systems audited as if they were fixed steel equipment, with no check of the supplier’s extractables basis or change-notification practice.
- A portable asset’s qualification tied to one room it no longer occupies, with no relocation trigger defined.
- A severity conclusion asserted without a documented count of Critical/Major/Minor findings behind it.
How to adapt this checklist
- Set the checklist number, site, and sample plan in the header before you start; draw the sample at random within risk-class strata, not from a list the site hands you.
- Skip Section 11 items (mark N/A) at a site with no single-use or portable assets in scope; do not delete the section, since a future audit at the same site may need it.
- Add equipment-family-specific items to Sections 4 and 5 if your site runs equipment types (bioreactors, tablet presses, molding equipment) with characteristic OQ/PQ tests not generic enough to list here.
- Feed every Fail into the paired audit findings report for individual severity classification, impact assessment, and CAPA ownership; this checklist scores the walkthrough, the report documents the disposition.
- Confirm every regulation cited in the Reference column against its current published version before you rely on it.