Published on 07/12/2025
How to Qualify Equipment in Pharma: Full Guide to IQ, OQ, PQ & DQ
1. Introduction to Equipment Qualification
Equipment Qualification (EQ) is a critical aspect of Good Manufacturing Practice (GMP) that ensures all equipment used in pharmaceutical production is installed, operated, and performs according to defined specifications. Before any production or analytical equipment is brought into routine use, it must go through a structured qualification process consisting of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This four-stage approach provides documented evidence that the equipment is fit for its intended purpose.
Global regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) all mandate equipment qualification as part of overall validation requirements. Specifically, FDA’s 21 CFR Part 211.63 requires that equipment be “of appropriate design, adequate size, and suitably located to facilitate operations.” Similarly, EU GMP Annex 15 outlines the need for planned qualification activities that are documented and justified.
Without proper qualification, even the most advanced equipment can become a source of variability, contamination, or non-compliance. Qualification not only ensures
2. Regulatory Framework and Global Guidelines
Equipment qualification is firmly embedded in international regulatory expectations and GMP frameworks. Regulators expect pharmaceutical manufacturers to implement a structured qualification program aligned with lifecycle principles and quality risk management strategies. The key references guiding these expectations include FDA 21 CFR Part 211, EU GMP Annex 15, WHO TRS 1019, and PIC/S PI 006.
The U.S. FDA does not explicitly mandate a DQ-IQ-OQ-PQ model but expects manufacturers to demonstrate that equipment is properly installed and capable of producing quality product consistently. This is interpreted through inspectional observations and enforcement actions. EMA’s Annex 15, however, directly defines the four stages of qualification and expects protocols and reports for each. It also integrates the concepts of design review, supplier qualification, and traceability throughout the equipment lifecycle.
The WHO’s TRS 1019 technical report emphasizes that qualification must be part of a broader validation program. It advocates for documented evidence, change control, and periodic requalification. The International Society for Pharmaceutical Engineering (ISPE) also provides practical guidance on qualification through its Good Practice Guides (e.g., for HVAC, sterile equipment, and calibration).
Globally, there’s a strong shift toward risk-based qualification strategies. ICH Q9 and Q10 promote the use of Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS) frameworks in qualification planning. Risk assessments guide the extent of qualification testing, selection of critical parameters, and justification for bracketing or reduced testing. Adherence to these frameworks ensures harmonized, compliant, and efficient qualification practices.
3. The Equipment Qualification Lifecycle
Equipment Qualification follows a well-defined lifecycle model that begins at the design stage and continues through installation, operation, performance, and finally, retirement or requalification. This lifecycle approach ensures that equipment remains in a validated state throughout its use, with all changes controlled and evaluated for impact.
Design Qualification (DQ) marks the beginning of this lifecycle. It confirms that the equipment design meets user requirements and GMP standards. DQ includes review of the equipment specifications, drawings, materials of construction, cleanability, automation, and integration with facility systems like HVAC or BMS. It’s performed before procurement and should be supported by documented User Requirement Specifications (URS) and Functional Design Specifications (FDS).
Installation Qualification (IQ) follows equipment delivery. It ensures that the equipment is received as designed, installed in accordance with manufacturer and engineering requirements, and that all utilities and documentation are in place. This includes checking power supplies, piping, alarms, software versions, calibration certificates, and mechanical integrity.
Operational Qualification (OQ) verifies that the equipment operates as intended across defined ranges. It involves testing critical parameters such as temperature, pressure, speed, flow, alarms, and interlocks. All testing is documented, deviations are investigated, and acceptance criteria must be predefined and justified.
Performance Qualification (PQ) validates that the equipment performs reliably during actual production conditions. This includes running product batches (or placebo where justified), assessing consistency, and confirming integration with cleaning and sampling procedures. For example, in a tablet press PQ, uniform tablet weight, hardness, and ejection must be demonstrated across multiple runs.
The lifecycle doesn’t end with PQ. Periodic review, preventive maintenance, requalification, and change control are necessary to maintain the qualified state. A well-maintained lifecycle ensures regulatory compliance and mitigates quality risks over the long term.
4. Design Qualification (DQ)
Design Qualification (DQ) is the initial step in the qualification lifecycle. It ensures that the design of the equipment aligns with the intended operational use, product requirements, and applicable GMP standards. DQ is a proactive process conducted before procurement, and its success determines the feasibility and future compliance of the equipment.
The foundation of DQ lies in a clearly defined User Requirement Specification (URS), which outlines what the equipment must achieve. It includes specifications related to production capacity, material compatibility, cleanability, control systems, alarms, safety features, and integration with existing systems. These requirements are translated into a Functional Design Specification (FDS) and Technical Design Specification (TDS) by the vendor or engineering team.
During DQ, the manufacturer or validation team reviews these specifications to confirm they meet process needs and regulatory expectations. This includes assessing the equipment layout, material of construction (e.g., SS316L for product contact parts), surface finish (e.g., Ra < 0.8 μm), and clean-in-place (CIP) capability if applicable. Control system design, automation interfaces, software validation requirements, and adherence to safety standards are also evaluated.
Documentation generated during DQ includes the URS, FDS, DQ protocol, traceability matrix, risk assessment report, and approvals from stakeholders in engineering, QA, and production. If conducted thoroughly, DQ reduces the risk of costly design changes, project delays, or GMP non-compliance post-installation.
In some projects, DQ is combined with Factory Acceptance Testing (FAT), allowing validation teams to witness performance against the URS at the vendor’s site. This integration saves time and identifies design flaws early in the project lifecycle.
5. Installation Qualification (IQ)
Installation Qualification (IQ) is the process of verifying and documenting that equipment is delivered, installed, and configured in accordance with approved design specifications and manufacturer recommendations. IQ ensures that the physical and environmental installation meets GMP requirements and that the equipment is ready for operational testing.
The IQ protocol includes a checklist of items to be verified. These typically cover:
- Equipment delivery inspection (check for damage, model number, serial number)
- Installation location and conditions (cleanroom classification, ventilation, space)
- Verification of utilities (electrical, steam, air, water) and connections
- Review of calibration status of critical instruments
- Checking of lubrication points and maintenance access
- Presence and completeness of documentation (manuals, certificates, P&IDs, software version control)
- Asset tagging and labelling as per site standards
All activities must be documented, deviations investigated, and reports signed off by QA. Photographic evidence, engineering sign-offs, and equipment layout drawings are often included as annexures. IQ also ensures that the equipment is integrated properly into the facility’s cleaning and maintenance programs.
Any discrepancies during IQ, such as missing documentation, uncalibrated gauges, or incompatible fittings, must be addressed through formal change control or deviation systems. IQ must be approved before proceeding to Operational Qualification (OQ).
6. Operational Qualification (OQ)
Operational Qualification (OQ) is the phase of equipment qualification where the equipment is rigorously tested to confirm that it operates according to its functional specifications. This step ensures that all critical components and controls perform reliably across defined operational ranges. OQ is essential for verifying alarms, interlocks, sensors, control panels, and software under simulated or controlled conditions.
The OQ protocol includes detailed testing procedures for each critical parameter. For example, a depyrogenation tunnel may be tested for belt speed, airflow distribution, and temperature uniformity; a granulator may be assessed for blade speed, spray rates, and bowl discharge controls. Alarms such as overtemperature, pressure loss, or motor overload are also challenged to confirm functionality.
OQ test cases typically involve:
- Set point verification and deviation handling
- Equipment interlock functionality
- Alarm verification (audible/visual and response)
- Control system navigation and data logging
- Programmable logic controller (PLC) validation if applicable
- Calibration verification of instruments
All test results must be recorded in real time, signed, and reviewed. Deviations from expected outcomes require root cause analysis, CAPA implementation, and retesting where needed. Any changes must be documented through change control. Completion of successful OQ testing and approval by QA is mandatory before proceeding to PQ.
In modern validation practices, risk-based approaches allow reduced testing for non-critical functions, provided the rationale is scientifically justified. The use of pre-approved templates, checklists, and traceability matrices strengthens compliance and consistency across qualification projects.
7. Performance Qualification (PQ)
Performance Qualification (PQ) is the final stage of the qualification lifecycle and provides documented evidence that the equipment can consistently perform its intended function under routine production conditions. It confirms that the equipment delivers reproducible results with actual product or placebo, under normal operating parameters.
PQ is typically conducted after successful completion of IQ and OQ, and includes:
- Running at least three consecutive successful batches
- Monitoring critical quality attributes (CQAs) of the product
- Evaluating in-process control (IPC) results and batch records
- Ensuring integration with cleaning procedures and support systems
For example, during the PQ of a tablet press, the validation team would monitor tablet weight, thickness, hardness, and friability across multiple runs. Any equipment alarms, stoppages, or deviations are documented and investigated. Similarly, the PQ of an autoclave may involve biological indicator (BI) challenges at multiple locations to confirm sterility assurance.
PQ should also demonstrate compliance with user requirements and alignment with the process validation strategy. The data collected during PQ is used to finalize standard operating procedures (SOPs), user training, and cleaning instructions. Upon successful PQ, the equipment is formally released for GMP use and transferred to the maintenance and calibration program for ongoing monitoring.
8. Equipment Qualification Documentation
Proper documentation is a cornerstone of a successful qualification program. Regulatory authorities expect clear, consistent, and traceable records at every stage of the qualification lifecycle. Each phase—DQ, IQ, OQ, PQ—requires its own protocol and report, and all documents must be reviewed and approved by cross-functional stakeholders including Engineering, QA, Production, and Validation.
Key documents in equipment qualification include:
- User Requirement Specifications (URS)
- Design Qualification (DQ) report
- Installation Qualification (IQ) protocol and report
- Operational Qualification (OQ) protocol and report
- Performance Qualification (PQ) protocol and report
- Change control records and deviation reports
- Risk assessment matrices
- Traceability matrix (linking URS to test cases)
- Calibration certificates and maintenance logs
Each document must include version control, signatures, execution dates, and annexures as needed. Documentation should be stored in accordance with the site’s Data Integrity policy, aligned with ALCOA+ principles—Attributable, Legible, Contemporaneous, Original, Accurate, and complete with enduring and secure records.
Well-organized documentation supports internal audits, regulatory inspections, and technology transfers. It also provides a foundation for future requalification, equipment upgrades, or troubleshooting investigations.
Conclusion
Equipment Qualification is a non-negotiable element of pharmaceutical quality systems. It ensures that equipment performs reliably, safely, and compliantly throughout its operational life. Whether it’s a simple balance or a complex lyophilizer, the principles of DQ, IQ, OQ, and PQ apply universally—anchored in science, risk-based thinking, and regulatory expectations.
By following a structured qualification lifecycle, backed by robust documentation and cross-functional collaboration, pharmaceutical companies not only meet compliance obligations but also improve process robustness, minimize downtime, and safeguard patient safety. With increasing automation, digitalization, and regulatory focus on data integrity, the importance of sound equipment qualification practices continues to grow.
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