IQ, OQ, PQ in pharmaceuticals

What are IQ, OQ, and PQ in pharma – and where does it sit in the lifecycle?

Before you write a protocol, align with the terminology. IQ verifies correct installation against design and vendor specs, OQ challenges functions and alarms under defined conditions, and PQ demonstrates performance in routine use for the intended process and load. In a typical lifecycle, Design Qualification (DQ) precedes installation, then IQ/OQ/PQ establishes initial qualification. Ongoing qualification relies on change control, calibration, monitoring, and defined requalification triggers.

Also read: GxP glossary

How do you plan IQ, OQ, PQ so execution is smooth?

A good plan prevents deviations later. Start by confirming user requirements and regulatory expectations, defining acceptance criteria that are objective and measurable, and decide how evidence will be captured and reviewed.

• Scope and URS: Confirm the equipment purpose, ranges, loads, and critical functions; define what must be proven and why.
• Risk assessment: Identify failure modes that could impact product quality or data integrity; use this to prioritize tests.
• Acceptance criteria: Write criteria that are specific and binary; tie them to standards, guidance, and URS needs.
• Data integrity: Define how raw data, calibration certs, and audit trails are collected, protected, and reviewed.
• Roles and approvals: Assign who prepares, executes, reviews, and approves to avoid gaps and delays.

Also read: WHO temperature mapping guidelines

How do you perform installation qualification (IQ)?

IQ verifies that the unit was delivered, installed, and configured as intended. The outcome is a traceable baseline that which future changes can be compared against.

• Identification and documentation: Record model, serial, firmware, and accessories; capture manuals and drawings.
• Utilities and environment: Verify electrical supply, ventilation, space, and any constraints discussed in DQ or URS.
• Calibration and certificates: Verify traceable calibration for sensors and references, ideally through ISO/IEC 17025 accredited calibration labs.
• Configuration and software: Record alarm setpoints, roles, and permissions; confirm audit trail is enabled when relevant.
• Change control baseline: Freeze the qualified configuration; document how future changes will be assessed.

How do you perform operational qualification (OQ)?

OQ challenges functions and alarms against predefined acceptance criteria. The focus is on demonstrating that controls respond correctly to normal and stressed conditions.

• Functional tests: Verify user controls, displays, door switches, and safety features behave as specified.
• Alarm challenges: Challenge high and low temperature alarms and associated notifications; document response time.
• Mapping for functionality: Conduct functional mapping to identify control stability and uniformity patterns. This is usually performed with empty or defined test loads.
• Recovery and hold tests: Challenge door openings or simulated heat ingress; evaluate recovery time and stability.
• Data integrity checks: Confirm time sync, audit trail, and user permissions; verify that data export is complete and traceable.

Also read: Guidelines for GxP temperature mapping

How do you perform performance qualification (PQ)?

PQ demonstrates that the unit performs in routine, real-world use – with typical loads, operating patterns, and procedures. PQ is often where qualification connects to day-to-day monitoring and deviation handling.

• Representative loads: Qualify with realistic product or simulants and typical loading patterns; justify worst-case placements.
• Temperature mapping in operation: Map under steady-state conditions to verify uniformity and critical control points.
• Process capability: Evaluate excursions, alarm handling, and corrective actions over a defined period.
• Documentation and sign-off: Consolidate raw data, calibration certs, and mapping results into a clear report; close deviations with root cause and CAPA.

Where incubators or controlled stability chambers are concerned, PQ should be aligned with ICH Q1A principles on stability testing.

Also read: Continuous temperature mapping service for GMP and GDP - how does it work?

What documentation do auditors check during IQ, OQ, and PQ?

Clear documentation proves control. Auditors will look for traceability from URS and risk assessment through executed test evidence, approvals, and change control. Digital records reduce errors and help you generate complete audit packs in minutes.

• Traceability matrix: Map URS and risks to protocol tests and acceptance criteria; show coverage.
• Raw data and reports: Keep mapping files, sensor IDs, and calibration certificates linked to the exact tests.
• Deviations and CAPA: Document any out-of-tolerance results with impact assessment, root cause, and actions.
• Change control and requalification: Define triggers such as repairs, relocation, software updates, out-of-tolerance calibrations, or negative trend analysis.

If electronic records are used, ensure compliance with FDA 21 CFR Part 11 and EU Annex 11 requirements.

Also read: How to write a URS for pharmaceutical storage areas and TCUs

What are the most common challenges – and how do teams reduce rework?

Validation work often becomes a bottleneck when qualification tasks compete with daily operations. Delays frequently stem from manual documentation, inconsistent templates, tight timelines for new sites, and fragmented vendors across mapping, monitoring, and calibration. A harmonized approach reduces idle time and audit risk.

• Standardize templates: Use reusable protocols and test plans across sites to speed execution and reviews.
• Combine mapping, monitoring, and calibration: One provider and one platform reduce handovers and errors.
• Digital audit packs: Automate record collection so complete reports can be exported quickly when audits hit.
• Continuous verification: Use continuous mapping and clear risk assessments to reduce periodic re-mapping work.

Also read: Our continuous mapping solution

How do you keep equipment qualified over time – without constant re-mapping?

Requalification consumes resources when it relies on repeated, manual studies. Many teams minimize repeat work by establishing robust monitoring, aligning mapping and monitoring data models, and using risk-based triggers for requalification. With a continuous mapping approach, a strategically denser sensor setup, and digital risk assessment can provide ongoing evidence, reducing the frequency of disruptive studies.

• Align mapping and monitoring: Use compatible sensors and IDs so operational data supports qualification claims.
• Define clear triggers: Re-qualify on significant changes, repeated deviations, major repairs, relocation, or negative trend analysis.
• Central oversight: Use dashboards to compare sites and spot trends before they become deviations.
• Speed up audits: Keep calibration certs, deviations, and mapping records in one system for rapid export.

Also read: Guidelines for risk-based temperature mapping