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• Validation Approach
  • Validation Vital Role
  • Validation Steps, V-Model
  • Qualification Phases↓
    • Design Qualification
    • Installation Qualification
    • Operational Qualification
    • Performance Qualifications
    • Process Validation
  • Sequential Validation
  • Validation vs Qualification
  • Validation vs Testing
  • Protocol and Final Report
  • Validation Master Plan
  • Validation Life Cycle
  • Change Control Impact
• Regulations
  • Medical Devices↓
    • Quality System Regulation (QSR)
    • QSR vs ISO 13485
    • QMSR FDA Final Rule
  • Pharmaceutical Manufacturing
  • Biopharmaceutical Production
  • Compounding Pharmacies
  • Cosmetic Product
• Requalification
  • Periodic Assessment
  • Requalification
• Risk Analysis
  • Risk Based Validation Approach
  • Failure Tree Analysis
  • Risk Assessment and Analysis
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Operational Qualification

Operational Qualification (OQ) is a phase in the validation process, particularly in regulated industries such as pharmaceuticals, biotechnology, medical devices, and others. The purpose of OQ is to confirm that the equipment or system operates as intended within its operational limits. It builds upon the Installation Qualification (IQ) phase, ensuring that the equipment functions properly and consistently.

Scope of Operational Qualification (OQ):

1. Equipment Verification: Verify that the equipment functions as intended and that all critical components are operational.
2. Performance Testing: Conduct tests to ensure that the equipment can perform its intended functions within specified parameters.
3. Operating Procedures: Evaluate and verify that the equipment operates in accordance with its documented operating procedures.
4. Critical Parameters: Identify and test critical parameters that are essential for the equipment's proper function and product quality.
5. Alarm and Safety Checks: Confirm that alarms, safety interlocks, and emergency shutdown systems are functioning as designed.
6. User Training: Ensure that personnel operating the equipment have received the necessary training and are competent in its use.
7. Data Logging and Monitoring: Validate that data logging and monitoring systems are functioning correctly and that data can be retrieved and stored as required.
8. Documentation Compliance: Verify that all documentation, including standard operating procedures and user manuals, is accurate and up to date.

OQ Protocol Content:

The OQ protocol is a formal document that outlines the procedures to be followed during the OQ process. Here's how to write an OQ protocol:

1. Title and Approval: Begin with a clear and descriptive title for the protocol and include spaces for approval signatures from relevant personnel.
2. Scope: Define the scope of the OQ, specifying the equipment or systems to be qualified and the boundaries of the study.
3. Purpose: State the purpose of the OQ, which is to verify that the equipment functions as intended within its operational parameters.
4. Responsibilities: List the roles and responsibilities of individuals involved in the OQ, such as the project manager, operators, and quality assurance personnel.
5. Equipment Details: Provide detailed information about the equipment, including model numbers, serial numbers, and any relevant drawings or schematics.
6. Performance Testing: Specify the procedures and acceptance criteria for performance testing, including all test scenarios, conditions, and parameters.
7. Operating Procedures: Describe how the equipment should be operated, and confirm that it operates according to documented procedures.
8. Critical Parameters: Identify critical parameters, define their acceptable ranges, and document the testing and results for these parameters.
9. Alarm and Safety Checks: Outline procedures for testing and verifying the effectiveness of alarms and safety interlocks.
10. User Training Verification: Confirm that personnel operating the equipment have received the necessary training and are competent in its use.
11. Data Logging and Monitoring: Detail how data logging and monitoring systems are tested, and confirm that they function correctly.
12. Documentation Compliance: Verify that all relevant documentation is accurate, up to date, and corresponds with the equipment's operation.
13. Conclusion: Summarize the results of the OQ, indicating whether the equipment has passed all tests and meets operational requirements or if any corrective actions are required.
14. Appendices: Include any relevant forms, checklists, or supporting documents.
15. Signatures: Provide spaces for approval signatures from responsible parties, indicating that the OQ was conducted and reviewed as specified.