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IQ, OQ and PQ: Importance in GMP
By gmpinsiders
 JUL 16, 2024
 #IQ, #OQ, #PQ, #Qualification, #Validation
Table of Contents
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What is Installation Qualification (IQ)?
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What is Operational Qualification (OQ)?
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What is Performance Qualification (PQ)?
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Steps in the Validation Process
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Regulatory Requirements for IQ, OQ, and PQ
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FAQ
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
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Conclusion
The validation steps—Installation Qualification (IQ), Operational Qualification (OQ),
and Performance Qualification (PQ)—are vital for confirming that equipment and
systems are installed and functioning correctly and consistently.
This article details the importance, procedures, and regulatory standards associated
with IQ, OQ, and PQ, highlighting their roles in maintaining high-quality
manufacturing practices.
What is Installation Qualification (IQ)?
Installation Qualification (IQ) - The documented verification that
the facilities, systems, and equipment, as installed or modified,
comply with the approved design and the manufacturer's
recommendations.

- Annex 15
Before IQ, a Design Qualification (DQ) should be performed to verify that the
proposed design meets operational needs.
RELATED: Design Review and Design Qualification in the Pharmaceutical Industry
Key Objectives of IQ:
Verify Installation: Confirm that the equipment or system has been installed
according to the design specifications and manufacturer’s recommendations.
Ensure Completeness: Ensure all required components, documentation, and
utilities are present and correctly installed.
Baseline for Ongoing Validation: Establish a documented baseline for the
equipment’s condition and configuration, which is essential for future
qualification and validation efforts.
Key Elements of IQ
The key elements of IQ include:
Verification of Installation
Equipment Specifications: Check that the equipment matches the specified
design and that all components are installed as per the manufacturer’s
guidelines.
Utilities and Connections: Verify that all necessary utilities (electricity, water, air,
etc.) and connections (plumbing, wiring, etc.) are correctly installed and
functional.
Supporting Systems: Ensure that any supporting systems (e.g., HVAC,
compressed air, vacuum systems) are properly installed and operational.
Component and Part Verification
Parts List: Verify that all parts and components listed in the design
specifications and purchase order are present and correctly installed.
Material and Finish: Confirm that the materials used in the construction of the
equipment match the specifications, including surface finishes and coatings.
Instrument Calibration
Calibration Status: Ensure that all measuring and monitoring instruments
associated with the equipment are calibrated and that calibration certificates
are available.
Reference Standards: Use traceable calibration standards to verify the accuracy
of instruments.
Environmental and Safety Checks
Safety Systems: Verify that all safety systems and features (e.g., emergency
stops, alarms, interlocks) are installed and functional.
Environmental Conditions: Check that the installation environment meets the
required conditions, such as temperature, humidity, and cleanliness.
Documentation and Labeling
Identification Labels: Ensure all components and equipment are correctly
labeled with identification tags and serial numbers.
Documentation Review: Verify that all relevant documentation (e.g., user
manuals, maintenance manuals, engineering drawings) is available and up-todate.
IQ Documentation Requirements
Proper documentation is a cornerstone of the IQ process, providing a detailed record
that the equipment or system was installed correctly. Key documentation
requirements include:
1. Installation Qualification Protocol
Protocol Document: A detailed, pre-approved protocol outlining the scope,
objectives, and procedures for the IQ process.
Acceptance Criteria: Clearly defined acceptance criteria for each aspect of the
installation that will be verified.
2. Equipment Specifications and Manuals
Design Specifications: Documentation of the design specifications, including
technical drawings, parts lists, and manufacturer’s instructions.
User and Maintenance Manuals: Manufacturer’s manuals for operation,
maintenance, and troubleshooting of the equipment.
3. Calibration Certificates
Certificates: Calibration certificates for all measuring instruments, showing
traceability to national or international standards.
Calibration Records: Records of the calibration process, including dates, results,
and personnel involved.
4. Installation Checklists
Component Checklists: Detailed checklists for verifying the presence and
correct installation of all components and parts.
Utility Checklists: Checklists to confirm that all necessary utilities and
connections are in place and functional.
5. Test and Verification Records
Verification Results: Records of all tests and verifications performed during the
IQ process, including results and any deviations noted.
Corrective Actions: Documentation of any corrective actions taken to address
deviations or non-conformances found during installation.
6. Final Report
Summary Report: A comprehensive report summarizing the IQ process,
including the protocol, test results, deviations, corrective actions, and a
conclusion.
Approval Signatures: Signatures of the personnel who conducted the IQ, as well
as approvals from QA and other relevant departments.
What is Operational Qualification (OQ)?
Operational Qualification (OQ) – The documented verification that the facilities,
systems, and equipment, as installed or modified, perform as intended throughout
the anticipated operating ranges. (Annex 15)
OQ typically follows Installation Qualification (IQ), but for complex equipment, it can
be performed as a combined Installation/Operation Qualification (IOQ).
Key Elements of OQ
The key elements of OQ include:
Test Plan Development
Establishing a Detailed Test Plan: Outlining the procedures, acceptance
criteria, and test parameters. This plan should reflect the normal operating
conditions and the full range of operational settings.
Operational Tests
Conducting Tests: Verify the system’s functionality under various conditions,
including normal and stress conditions.
Tests Typically Cover:
Calibration checks
Control functions (e.g., alarms, interlocks)
Operational ranges
Software and automation systems
Safety features
Critical Parameter Verification
Identifying and Testing Critical Operational Parameters such as temperature,
pressure, speed, time, and other relevant parameters that could impact product
quality or process performance.
Challenge Tests
Performing Challenge Tests: To demonstrate that the system can handle
variations in operational conditions and still maintain performance. This may
include testing limits or worst-case scenarios.
Data Collection and Analysis
Collecting and Analyzing Data: From the tests to confirm that the equipment
or system meets the predefined criteria. This includes statistical analysis and
comparison with expected outcomes.
Deviation Management
Documenting and Addressing Deviations: From expected results. This involves
root cause analysis, corrective actions, and re-testing as necessary.
OQ Documentation Requirements
The key documentation requirements for OQ include:
1. OQ Protocol
A comprehensive document outlining the scope, objectives, responsibilities,
procedures, test methods, acceptance criteria, and references for the OQ
phase. The protocol must be approved before execution.
2. Test Plans and Procedures
Detailed test plans and standard operating procedures (SOPs) for conducting
each test. These documents ensure consistency and reproducibility of the OQ
process.
3. Test Records and Data
Complete and accurate records of all tests performed, including raw data, test
results, and observations. This documentation serves as evidence that the OQ
was conducted as per the protocol.
4. Calibration Certificates
Certificates or records of calibration for all measurement and test equipment
used during OQ. This ensures that the equipment used for testing is accurate
and reliable.
5. Deviation Reports
Reports detailing any deviations from the protocol, including the nature of the
deviation, investigation results, impact assessment, corrective actions taken, and
re-testing results.
6. Summary Report
A final report summarizing the OQ activities, results, and conclusions. This
report should state whether the equipment or system has met the acceptance
criteria and is suitable for proceeding to the next validation phase (Performance
Qualification).
What is Performance Qualification (PQ)?
Performance Qualification (PQ) – The documented verification that systems and
equipment can perform effectively and reproducibly based on the approved process
method and product specification. (Annex 15)
PQ ensures the equipment’s reliability and effectiveness in producing consistent
results over time.
Key Elements of PQ
The key elements of PQ include:
Sequential Validation and Integration
Sequential Approach: PQ usually follows the successful completion of IQ and
OQ to ensure that the equipment and systems are installed correctly (IQ) and
operate according to specifications (OQ).
Concurrent Validation: In certain scenarios, it may be appropriate to perform
PQ in conjunction with OQ or Process Validation. This approach can be practical
for processes with extensive historical data or well-established development
studies.
Scope of PQ Testing
PQ should include, but is not limited to, the following aspects:
a. Testing with Production Materials
Use of Actual Production Materials: PQ tests should be conducted using actual
production materials to simulate real manufacturing conditions.
Qualified Substitutes or Simulated Products: When actual production
materials are not feasible, qualified substitutes or simulated products proven to
have equivalent behavior can be used.
Worst Case Scenarios: Testing should include worst-case batch sizes to
challenge the system under the most demanding conditions expected in
routine production.
b. Frequency of Sampling
Justified Sampling Frequency: The frequency of sampling during PQ must be
justified and based on the criticality of the process parameters. It ensures
adequate process control and provides sufficient data to demonstrate consistent
performance.
3. Operational Range Testing
Covering Operating Range: PQ tests should encompass the entire operating
range of the intended process. This includes testing at the minimum, maximum,
and normal operating conditions to ensure the process is robust and capable of
producing quality products under varying conditions.
Documented Evidence: If there is documented evidence from the development
phases that confirms the operational ranges, this can be used to support the PQ
process. This evidence may include data from earlier development studies or
pilot-scale runs.
PQ Documentation Requirements
The key documentation for PQ include:
1. PQ Protocol
Scope and Objectives: Overview of the PQ process, including objectives and
scope.
Responsibilities: Clear definition of roles and responsibilities.
Procedures and Test Methods: Detailed description of procedures and
methods to be used.
Acceptance Criteria: Specific criteria that must be met for PQ to be considered
successful.
2. Test Plans and Procedures
Detailed Test Plans: Comprehensive plans outlining each test to be conducted.
Standard Operating Procedures (SOPs): SOPs to ensure consistency and
reproducibility.
3. Test Records and Data
Raw Data: Complete records of all tests performed, including raw data, test
results, and observations.
Data Analysis: Analysis of the test data, including statistical evaluations.
4. Calibration Certificates
Calibration Records: Certificates or records of calibration for all measurement
and test equipment used during PQ, ensuring accuracy and reliability.
5. Deviation Reports
Documentation: Detailed reports of any deviations from the protocol.
Investigation and Actions: Root cause analysis, impact assessment, corrective
actions taken, and re-testing results.
6. Summary Report
Summary of Activities: Overview of the PQ activities, results, and conclusions.
Conclusions: Statement on whether the equipment/system meets the
acceptance criteria and is suitable for production use.
Steps in the Validation Process
The key steps when performing IQ, OQ, and PQ include:
Step 1: Write and Develop the Protocol
When developing IQ, OQ or PQ Protocol here are the main factors to consider and
include:
1.1 Define the Scope and Objectives:
Scope: Clearly outline what the protocol will cover. This includes specifying the
equipment, system, or process being validated.
Objectives: Define the goals of the validation effort, such as ensuring
compliance with regulatory requirements, verifying performance specifications,
and establishing documented evidence of system suitability.
1.2 Assemble a Validation Team:
Include representatives from relevant departments such as Quality Assurance
(QA), Production, Engineering, and Validation.
Define the roles and responsibilities of each team member.
1.3 Develop the Validation Plan:
Plan Outline: Provide a high-level overview of the entire validation process.
Resources: List the resources required, including personnel, equipment, and
materials.
Schedule: Develop a timeline for the validation activities.
1.4 Draft the Protocol Document:
Protocol Title and Identification: Assign a unique title and identification
number to the protocol.
Introduction and Background: Describe the purpose of the protocol and
provide background information.
Scope: Reiterate the scope of the validation.
Responsibilities: Detail the responsibilities of each team member.
Acceptance Criteria: Define clear and measurable acceptance criteria for each
validation activity.
Procedure: Provide detailed step-by-step instructions for conducting the
validation.
Documentation: Specify the types of records that need to be kept and how they
should be documented.
Change Control: Outline the process for handling deviations and changes
during validation.
1.5 Review and Approval:
Circulate the draft protocol among key stakeholders for review.
Address any comments or concerns raised during the review.
Obtain formal approval from relevant authorities, such as QA and regulatory
affairs.
Step 2: Execute an IQ, OQ, or PQ Protocol
2.1 Preparation for Execution:
Training: Ensure that all personnel involved in the validation have received
proper training on the protocol and the equipment or process being validated.
Equipment and Materials: Confirm that all necessary equipment and materials
are available and in good working condition.
Documentation: Prepare all forms, checklists, and data sheets required for
recording validation results.
2.2 Conduct Installation Qualification (IQ):
Purpose: Verify that the equipment or system is installed correctly and
according to the manufacturer’s specifications.
Procedure:
Verify the installation site environment.
Check and document the condition and presence of all components.
Confirm that the equipment is installed according to the design
specifications.
Verify that all utilities (e.g., electrical, water, air) are correctly connected.
Review calibration and maintenance records.
Documentation: Record all findings, including any discrepancies and actions
taken to resolve them.
2.3 Conduct Operational Qualification (OQ):
Purpose: Ensure that the equipment or system operates as intended
throughout all anticipated operating ranges.
Procedure:
Develop and execute test cases that cover all functional aspects of the
equipment or system.
Verify that operational controls, alarms, and interlocks function correctly.
Perform repeated tests to demonstrate consistent performance.
Document test results, deviations, and corrective actions.
Acceptance Criteria: Results must meet predefined acceptance criteria to
confirm that the equipment or system operates correctly.
2.4 Conduct Performance Qualification (PQ):
Purpose: Demonstrate that the equipment or system performs consistently and
effectively under real-world conditions.
Procedure:
Develop test cases that simulate normal operating conditions.
Include tests for all critical parameters and performance characteristics.
Monitor the system over an extended period to ensure consistent
performance.
Document all results, including any deviations and corrective actions.
Documentation: Compile all data and evidence showing that the system
performs as expected in the actual production environment.
2.5 Review and Report:
Review: Conduct a thorough review of all documentation and results from IQ,
OQ, and PQ activities.
Report: Prepare a comprehensive validation report that summarizes the
findings, including any deviations and how they were addressed.
Approval: Obtain final approval of the validation report from QA and other
relevant stakeholders.
2.6 Continuous Monitoring and Revalidation:
Establish a program for ongoing monitoring of the equipment or system to
ensure continued compliance.
Define criteria and a schedule for periodic revalidation based on changes to the
system or process or as part of routine quality assurance.
By following these steps meticulously, you can ensure that the validation process is
thorough, systematic, and compliant with GMP guidelines.
Regulatory Requirements for IQ, OQ, and PQ
The regulatory requirements for Installation Qualification (IQ), Operational
Qualification (OQ), and Performance Qualification (PQ) in Good Manufacturing
Practice (GMP) are outlined by various international regulatory bodies such as the
FDA (Food and Drug Administration) and EMA (European Medicines Agency). These
qualifications are essential components of the validation process for manufacturing
equipment, systems, and processes in the pharmaceutical industry. Below is a
detailed overview of the regulatory requirements:
FDA (Food and Drug Administration)
1. Code of Federal Regulations (CFR): The FDA’s requirements for IQ, OQ, and PQ
are detailed in 21 CFR Part 211 (Current Good Manufacturing Practice for Finished
Pharmaceuticals) and 21 CFR Part 820 (Quality System Regulation for Medical
Devices).
2. 21 CFR Part 211:
§211.68: Automated, mechanical, and electronic equipment should be routinely
calibrated, inspected, or checked according to a written program designed to
assure proper performance.
§211.100: Requires validation of all processes that could affect the quality of the
finished product, which includes equipment qualification.
§211.110: Outlines the need for validated methods to ensure batch uniformity and
integrity of drug products.
3. FDA Guidance Documents: The FDA provides several guidance documents that
elaborate on the expectations for equipment and process validation, including
the General Principles of Software Validation and the Guidance for Industry on
Process Validation: General Principles and Practices.
EMA (European Medicines Agency)
1. EudraLex – Volume 4 – GMP Guidelines: The EU GMP guidelines provide
detailed requirements for the qualification of equipment and validation of
processes in Part 1 (Basic Requirements for Medicinal Products) and Annexes.
2. Annex 15: Qualification and Validation:
Installation Qualification (IQ): Should demonstrate that the equipment has
been installed in accordance with the manufacturer’s specifications and
requirements.
Operational Qualification (OQ): Should demonstrate that the equipment
operates as intended throughout all anticipated operating ranges.
Performance Qualification (PQ): Should demonstrate that the equipment
consistently performs according to the process requirements in actual
production.
Key Sections in Annex 15:
Section 3.2: States that a risk-based approach should be used to determine the
extent of validation and qualification efforts.
Section 4.1: Emphasizes the importance of documented evidence that facilities,
systems, and equipment have been installed correctly (IQ), operate correctly
(OQ), and perform effectively and reproducibly (PQ).
Key Regulatory Expectations
Some of the key regulatory expectations when auditing IQ, OQ, and PQ include:
1. Risk-Based Approach
Regulatory bodies emphasize using a risk-based approach to determine the scope
and depth of IQ, OQ, and PQ activities. This involves identifying and mitigating risks
that could affect product quality and patient safety.
READ MORE: Quality Risk Management in the Pharmaceutical Industry
2. Comprehensive Documentation
Detailed documentation is required at each stage of the qualification process. This
includes protocols, test results, calibration records, deviation reports, and final
summary reports.
3. Change Control
A formal change control process should be in place to manage any modifications to
equipment, systems, or processes that may impact qualification status.
4. Periodic Review and Requalification
Periodic reviews and requalification should be conducted to ensure that equipment
and systems remain qualified throughout their lifecycle.
5. Training
Personnel involved in qualification activities should be adequately trained and
qualified to perform their duties.
FAQ
When Should IQ, OQ, and PQ Be Performed?


IQ: Conducted during the initial setup and installation of new equipment or systems, or
after relocation or major maintenance.
OQ: Performed after successful completion of IQ and before the equipment or system is
used for actual production. It can also be required after significant changes or upgrades.
PQ: Conducted after successful completion of both IQ and OQ, under actual production
conditions. It can also be performed periodically as part of routine requalification.

How Is PQ Different From OQ?


What Are the Acceptance Criteria for IQ, OQ, and PQ?


How Often Should Requalification (Revalidation) Be Performed?


Can IQ, OQ, and PQ Be Combined Into a Single Document?

Conclusion
The validation processes of IQ, OQ, and PQ in GMP environments are fundamental in
pharmaceutical manufacturing. They ensure that equipment is installed accurately,
operates within designated limits, and performs consistently under actual
production conditions.
These qualifications are essential for meeting regulatory standards and ensuring the
safety and efficacy of pharmaceutical products. By rigorously applying these
protocols, manufacturers uphold quality and reliability, building trust among
healthcare providers, regulators, and patients.
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