Commissioning and Qualification

1. Planning: Develop a comprehensive C&Q plan that outlines the scope, objectives, methodologies, responsibilities, and timelines for the commissioning and qualification activities. This plan should align with regulatory requirements and project objectives.

2. Design Qualification (DQ): Verify that the design of facilities, equipment, utilities, and systems meets the intended requirements and specifications. This involves reviewing design documents, specifications, drawings, and vendor documentation to ensure compliance with regulatory standards and industry best practices

33 Installation Qualification (IQ): Ensure that equipment, utilities, and systems are installed correctly and in accordance with approved design specifications. This includes verifying equipment installation, utility connections, instrumentation, and alignment with architectural and engineering drawings.

4. Operational Qualification (OQ): Verify that equipment, utilities, and systems operate effectively and consistently within predefined operational ranges. This involves testing individual components, functionalities, and performance characteristics to ensure they meet specified requirements.

5. Performance Qualification (PQ): Demonstrate that equipment, utilities, and systems perform reliably and consistently under simulated or actual operating conditions. This involves testing the integrated system to ensure it meets predefined performance criteria, quality standards, and regulatory requirements.

6. Documentation and Reporting: Maintain comprehensive documentation throughout the commissioning and qualification process, including protocols, test scripts, test results, deviations, corrective actions, and final reports. All activities and findings should be documented in a clear, traceable, and auditable manner

7. Change Control : Implement a robust change control process to manage any changes or modifications to equipment, utilities, and systems following qualification. Changes should be evaluated, documented, and validated to ensure they do not adversely affect product quality, safety, or regulatory compliance.

8. Training and Personnel Qualification: Provide training to personnel involved in the commissioning and qualification activities to ensure they have the necessary knowledge, skills, and competencies to perform their roles effectively. Personnel qualifications should be documented and maintained to demonstrate compliance with regulatory requirements.

9. Periodic Review and Requalification: Regularly review and reassess the performance of qualified equipment, utilities, and systems to ensure continued compliance with regulatory standards and evolving business needs. Requalification may be necessary following significant changes, maintenance activities, or upgrades to the system.

10. Audit and Inspection Readiness: Prepare for regulatory audits and inspections by maintaining accurate and up-to-date documentation, records, and evidence of compliance with commissioning and qualification requirements. Address any audit findings or observations promptly and implement corrective actions as necessary.