All processes and equipment within pharmaceutical manufacturing must function correctly at all times, not just sometimes or nearly correctly but with absolute certainty. Such confidence in an equipment or manufacturing process comes from a formalized qualification method that outlines the four qualification phases for new equipment or systems (DQ, IQ, OQ, and PQ).
Of these four phases, the OQ phase is the link between two consecutive phases of qualification. OQ verifies that all equipment or systems used in pharmaceutical manufacturing operate properly before they manufacture and come into contact with pharmaceutical products.
In other words, OQ is an assessment of how well a manufacturer can operate its equipment or system under all potential scenarios, including "best case" (normal conditions) and "worst case" (challenges).
This will involve assessing and verifying the performance of control systems, alarms and interlocks, sensors, and other operational aspects which will help ensure that the equipment and systems are reliable and safe to use.
Ultimately, OQ answers this question: “Does the system operate as intended – accurately, repeatedly and safely?"
- The equipment operates according to the design specifications and user requirements.
- All control functions and automation systems operate correctly.
- Instruments, sensors and alarms are operating within their acceptable limits.
- Software and data recording systems are validated.
- Safety systems and interlocks are functioning as intended.
- All Standard Operating Procedures (SOPs) are verified for functionality.
Essentially, OQ confirms that the installation of equipment is sufficient for successful operation, which is needed before any material produced can be processed further.
In general, the validation sequence is outlined below:
1. Design Qualification: It confirms that the equipment functionally meets the requirements of the user department and also the design of the equipment.
2. Installation Qualification: It determines that the equipment was installed properly, functions safely and the equipment is ready for use.
3. Operational Qualification: OQ verifies that all functions of the equipment are working as expected.
4. Performance Qualification: The purpose of a PQ is to determine that the equipment will operate correctly when used in actual operational conditions.
Once the IQ and OQ are completed, the equipment or system can proceed to the PQ phase and later to routine use as part of good manufacturing practices.
European Union Good Manufacturing Practice (EU GMP) - Annex 15 "The operational qualification of the equipment, utility and systems shall establish that they will perform correctly in accordance with their intended use."
World Health Organisation (WHO) Technical Report Series No. 937 - Annex 4 "OQ will confirm that all critical parameters are maintained in their defined limits during use."
International Society for Pharmaceutical Engineering (ISPE) Baseline Guide - Volume 5 Defines OQ as the process of confirming that all functional capabilities of the equipment are being demonstrated in the full range of intended use conditions; therefore, OQ verifies both operation and capability.
U.S. Food and Drug Administration (FDA) 21 CFR Part 211.68 and 211.100 describe that the calibration and performance Verify the automatic, mechanical, and electronic equipment.
OQ is not a choice; it is a requirement of every major global GMP system.
- Manufacturers equipment like Granulators, Autoclaves, Reactors, Filling Equipment
- Utilities including Purified Water System, HVAC Systems, Compressed Air
- Analytical Equipment like HPLC's, GC's, Dissolution Testers
- Computer-based Systems, including SCADA, PLC or MES
Other systems that produce items affecting directly either: Product, Quality or Patient Safety must be verified with an OQ prior to using them during GMP operations.
Download Operational Qualification Sample Protocol
- Start-Up and shut-down operation
- Control panel interface checks
- Sensor and probe response (temperature, pressure, flow)
- Interlock and alarm verification
- Data logging and trend analysis
- Safety features
- Backup and power failure recovery
Each test result must satisfy the acceptance criteria specified in the operation qualification protocol.
The following information must be recorded during the operational qualification (OQ):
1. Instrument Identification number, calibration date and calibration due date.
2. Verify instrument accuracy and repeatability.
3. Recalibrate or replace out of tolerance instruments.
Upon verifying the accuracy of calibrated instruments, the integrity of the data generated in testing the test is assured.
The type of tests that you will typically perform include:
- Testing for user access control and security levels.
- Testing for data recording, retrieval, and audit trail functionality.
- Testing for alarm configuration and interlocks.
- Testing for electronic signature verification.
- Testing for recipe management and batch record generation.
Performing hardware and software testing shows that the system will comply with the regulatory requirements for records and data integrity.
For example, you might test your system with:
1. Temperature Chambers - Cold and hot temperatures at extreme, low, and high will be checked for temperature uniformity.
2. Autoclaves - Biological indicators are used to verify that the sterilization cycle has been completed properly and under control according to time and exposure temperature.
3. HVAC systems - Alarms will be activated when the temperature or relative humidity goes beyond a specified range.
These tests demonstrate that the system continues to operate within controlled limits providing assurance of stability under stress tests during OQ.
Engineering: Supply technical support and instrument data information.
Quality Assurance (QA): Reviews, approves and responsible for ensuring GMP compliance.
User Department: Responsible for validating the equipment will be operated in according to the best practices and that the operating procedures are aligned with the SOPs.
Suppliers: Provide support and documentation during testing.
1. Incomplete protocols: Missing tests to be performed or unclear acceptance criteria.
2. Instruments not calibrated: Invalid test results.
3. Lack of proper software validation: Equipment or system is not checked for 21 CFR Part 11 compliance.
4. No challenge testing done: Performance of equipment or system is not confirmed.
5. Documentation gaps: Signatures and calibration records are missing.
Any of these issues can cause delays in qualification completion and observed during audits.
2. Perform risk-based testing on only those processes whose failure will compromise the quality of your product.
3. Use standardized templates to ensure compliance within departments.
4. Test alarm and interlock systems to ensure that safety is maintained and that appropriate control is exercised.
5. Train people that will be executing the logical process of execution; use only qualified personnel to perform OQ.
6. Create thorough documentation for OQ records, as audit regulators tend to examine OQ documentation closely.
In summary, strong OQ execution will reduce failure rates while producing your product.
OQ = Verification that a system works correctly as designed.
PQ = Verification that a system is performing consistently and produces reproducible results.
Together, these three stages provide assurance that the equipment is 'fit for use' and suitable, safe and compliant from installation to performance.
OQ is an important step in the process of validating pharmaceutical products because it connects the verification of installation to actual operation of the product by confirming that each control, sensor and alarm is working correctly. If done properly, the OQ creates reliable equipment, accurate data collection and protection of patient safety. These are the foundations for producing high-quality pharmaceutical products.
Failing to perform or inadequately performing the OQ will provide short-term relief but create a high degree of risk for future compliance and possible production delays and the potential for regulatory penalties. Performing the OQ with proper documentation and based on risk will allow for auditing of the system, while at the same time creating a good basis of confidence in the system over time.
Of these four phases, the OQ phase is the link between two consecutive phases of qualification. OQ verifies that all equipment or systems used in pharmaceutical manufacturing operate properly before they manufacture and come into contact with pharmaceutical products.
What is Operational Qualification (OQ)?
The operational qualification (OQ) process allows manufacturers to confirm that their equipment and systems are performing according to the manufacturer's specifications within the defined limits of use.In other words, OQ is an assessment of how well a manufacturer can operate its equipment or system under all potential scenarios, including "best case" (normal conditions) and "worst case" (challenges).
This will involve assessing and verifying the performance of control systems, alarms and interlocks, sensors, and other operational aspects which will help ensure that the equipment and systems are reliable and safe to use.
Ultimately, OQ answers this question: “Does the system operate as intended – accurately, repeatedly and safely?"
Purpose of Operational Qualification
The purpose of Operational Qualification (OQ) is to ensure that:- The equipment operates according to the design specifications and user requirements.
- All control functions and automation systems operate correctly.
- Instruments, sensors and alarms are operating within their acceptable limits.
- Software and data recording systems are validated.
- Safety systems and interlocks are functioning as intended.
- All Standard Operating Procedures (SOPs) are verified for functionality.
Essentially, OQ confirms that the installation of equipment is sufficient for successful operation, which is needed before any material produced can be processed further.
When to Perform Operational Qualification?
Following completion of an installation qualification (IQ) and before performance qualification (PQ), an operational qualification (OQ) will take place.In general, the validation sequence is outlined below:
1. Design Qualification: It confirms that the equipment functionally meets the requirements of the user department and also the design of the equipment.
2. Installation Qualification: It determines that the equipment was installed properly, functions safely and the equipment is ready for use.
3. Operational Qualification: OQ verifies that all functions of the equipment are working as expected.
4. Performance Qualification: The purpose of a PQ is to determine that the equipment will operate correctly when used in actual operational conditions.
Once the IQ and OQ are completed, the equipment or system can proceed to the PQ phase and later to routine use as part of good manufacturing practices.
Regulatory Expectations for Operational Qualification
All regulatory agencies require Operational Qualification (OQ) to be performed in conjunction with the entire validation cycle.European Union Good Manufacturing Practice (EU GMP) - Annex 15 "The operational qualification of the equipment, utility and systems shall establish that they will perform correctly in accordance with their intended use."
World Health Organisation (WHO) Technical Report Series No. 937 - Annex 4 "OQ will confirm that all critical parameters are maintained in their defined limits during use."
International Society for Pharmaceutical Engineering (ISPE) Baseline Guide - Volume 5 Defines OQ as the process of confirming that all functional capabilities of the equipment are being demonstrated in the full range of intended use conditions; therefore, OQ verifies both operation and capability.
U.S. Food and Drug Administration (FDA) 21 CFR Part 211.68 and 211.100 describe that the calibration and performance Verify the automatic, mechanical, and electronic equipment.
OQ is not a choice; it is a requirement of every major global GMP system.
Scope of Operational Qualification
OQ applies to:- Manufacturers equipment like Granulators, Autoclaves, Reactors, Filling Equipment
- Utilities including Purified Water System, HVAC Systems, Compressed Air
- Analytical Equipment like HPLC's, GC's, Dissolution Testers
- Computer-based Systems, including SCADA, PLC or MES
Other systems that produce items affecting directly either: Product, Quality or Patient Safety must be verified with an OQ prior to using them during GMP operations.
Operational Qualification Process
The Operational Qualification (OQ) of a product is performed according to a defined and documented methodology. The OQ involves developing an OQ Protocol, executing the OQ tests, addressing any deviation, preparing report for the OQ activities and obtaining final approval.A. Preparation of OQ Protocol
The OQ Protocol will typically include:- Define objectives and the scope of testing
- Provide equipment identification details
- Provide reference documents (URS, DQ and IQ)
- Define responsibilities and approvals
- List the test instrumentation and calibration references
- Provide a list of test cases and acceptance criteria
- Define the process for handling deviations
Download Operational Qualification Sample Protocol
B. Verification of Operational Parameters
The Operational Qualification (OQ) phase is a process of verifying that each functional element of the equipment is working as intended through checks of the following:- Start-Up and shut-down operation
- Control panel interface checks
- Sensor and probe response (temperature, pressure, flow)
- Interlock and alarm verification
- Data logging and trend analysis
- Safety features
- Backup and power failure recovery
Each test result must satisfy the acceptance criteria specified in the operation qualification protocol.
C. Calibration and Instrument Verification
Before the initial testing of any measuring equipment, all calibrations must have traceable certification against a recognized national or internationally recognized standard.The following information must be recorded during the operational qualification (OQ):
1. Instrument Identification number, calibration date and calibration due date.
2. Verify instrument accuracy and repeatability.
3. Recalibrate or replace out of tolerance instruments.
Upon verifying the accuracy of calibrated instruments, the integrity of the data generated in testing the test is assured.
D. Software and Automation Testing
Most modern pharmaceutical companies employ computerized systems to manage automated processes. If you are responsible for the operational qualification (OQ) of an automation system, you should conduct tests to show that the automation works as designed and meets both 21 CFR Part 11 (Electronic Records and Signatures) and GAMP 5 principles.The type of tests that you will typically perform include:
- Testing for user access control and security levels.
- Testing for data recording, retrieval, and audit trail functionality.
- Testing for alarm configuration and interlocks.
- Testing for electronic signature verification.
- Testing for recipe management and batch record generation.
Performing hardware and software testing shows that the system will comply with the regulatory requirements for records and data integrity.
E. Challenge Testing
Challenge testing is a means of testing how your system responds to extreme or fault conditions.For example, you might test your system with:
1. Temperature Chambers - Cold and hot temperatures at extreme, low, and high will be checked for temperature uniformity.
2. Autoclaves - Biological indicators are used to verify that the sterilization cycle has been completed properly and under control according to time and exposure temperature.
3. HVAC systems - Alarms will be activated when the temperature or relative humidity goes beyond a specified range.
These tests demonstrate that the system continues to operate within controlled limits providing assurance of stability under stress tests during OQ.
F. Deviation Handling in Operational Qualification
Deviation refers to any discrepancies observed between what was expected versus what actually happened and recorded accordingly. When documenting a deviation there are four components that must be included:- Description of the problem.
- Investigation of root causes.
- Corrective and Preventive Action (CAPA).
- Quality Assurance (QA) review and closure.
G. Prepare the OQ Report
Once the operational qualification has been completed, the OQ report will compile all of the data pertaining to the outcome of the qualification test and identify the outcomes to the constituents involved in the process. The contents of the OQ report include:- Summary of qualifications test and the results
- Certificates of calibration
- Summary of deviations and resolution
- Conclusion and QA signature/approval
Roles and Responsibilities in Operational Qualification
Validation Team: Responsible for generating and executing the OQ protocol.Engineering: Supply technical support and instrument data information.
Quality Assurance (QA): Reviews, approves and responsible for ensuring GMP compliance.
User Department: Responsible for validating the equipment will be operated in according to the best practices and that the operating procedures are aligned with the SOPs.
Suppliers: Provide support and documentation during testing.
Common Challenges During Operational Qualification
Challenges occur during the execution of the operational qualification are:1. Incomplete protocols: Missing tests to be performed or unclear acceptance criteria.
2. Instruments not calibrated: Invalid test results.
3. Lack of proper software validation: Equipment or system is not checked for 21 CFR Part 11 compliance.
4. No challenge testing done: Performance of equipment or system is not confirmed.
5. Documentation gaps: Signatures and calibration records are missing.
Any of these issues can cause delays in qualification completion and observed during audits.
Best Practices for OQ Execution
1. Start planning for OQ as soon as you begin the design and procurement of equipment.2. Perform risk-based testing on only those processes whose failure will compromise the quality of your product.
3. Use standardized templates to ensure compliance within departments.
4. Test alarm and interlock systems to ensure that safety is maintained and that appropriate control is exercised.
5. Train people that will be executing the logical process of execution; use only qualified personnel to perform OQ.
6. Create thorough documentation for OQ records, as audit regulators tend to examine OQ documentation closely.
In summary, strong OQ execution will reduce failure rates while producing your product.
Relationship Between IQ, OQ, and PQ
IQ = Verification that the installation matches the design of the equipment or system.OQ = Verification that a system works correctly as designed.
PQ = Verification that a system is performing consistently and produces reproducible results.
Together, these three stages provide assurance that the equipment is 'fit for use' and suitable, safe and compliant from installation to performance.
Common OQ Documents and Attachments
The OQ package documentation is comprised of:- OQ Protocol and Report
- Calibration Certificates
- Instrument and Alarm Test Records
- Evidence of Software Validation
- Deviation and CAPA Records
- Training Certificates
- Quality Assurance Approval Forms
OQ is an important step in the process of validating pharmaceutical products because it connects the verification of installation to actual operation of the product by confirming that each control, sensor and alarm is working correctly. If done properly, the OQ creates reliable equipment, accurate data collection and protection of patient safety. These are the foundations for producing high-quality pharmaceutical products.
Failing to perform or inadequately performing the OQ will provide short-term relief but create a high degree of risk for future compliance and possible production delays and the potential for regulatory penalties. Performing the OQ with proper documentation and based on risk will allow for auditing of the system, while at the same time creating a good basis of confidence in the system over time.
Frequently Asked Questions (FAQs) on Operational Qualification
Q1. What is Operational Qualification (OQ)?
Answer: OQ determines that systems or equipment properly function as intended within established limits and they will function as intended in accordance with the applicable Good Manufacturing Practice (GMP) principles.Q2. When is OQ performed?
Answer: OQ occurs following installation qualification (IQ) and before performance qualification (PQ).Q3. Why is OQ important?
Answer: If the system is to be relied upon by the manufacturer to produce a consistent quality product in accordance with federal regulations, it has to be demonstrated to function consistently, reliably, safely and within specified limits prior to the start of production.Q4. What tests are included in OQ?
Answer: The types of tests performed during an OQ assessment include functional checks for all control systems, alarm verification, calibration & challenge testing.Q5. Who performs OQ in pharmaceuticals?
Answer: OQ is conducted by validation or quality assurance teams with assistance from engineering or the vendor who is supplying the equipment or system following a pre-approved protocol.Q6. What is challenge testing in operational qualification?
Answer: Challenge testing allows to know how well a system operates under abnormal or stressed conditions and provides evidence that the system is stable and controlled.Q7. What documents are required for operational qualification?
Answer: Documents necessary for OQ include OQ protocol, OQ test records, calibration certificates, deviation reports, and OQ summary reports.Q8. How are OQ and PQ different?
Answer: OQ verifies operational capability of an equipment or system while PQ informs about the consistency of an equipment or system performance with actual production materials.
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