Understanding Qualification File Requirements for New Machines in Pharma as per WHO/EU/USFDA

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1. Change Control: Systematic management of equipment changes to avoid quality impacts.
2. User Requirements Specification (URS): Detailed equipment requirements document.
3. Area Diagram: Visual layout depiction of the installation area.
4. Design Qualification (DQ): Verification that equipment design meets URS.
5. Operational Manual (Control Copy): Essential instructions for operation, maintenance, and troubleshooting.
6. Factory Acceptance Test (FAT): Supplier site testing to ensure compliance with design, including sample collection.
7. Site Acceptance Test (SAT): On-site testing to verify equipment functionality as per URS and DQ.
8. Draft Standard Operating Procedures (SOP): Initial version of operational procedures.
9. Installation Qualification (IQ): Verification of correct installation and personnel training.
10. Gap Assessments for Installation Qualification: Identifying discrepancies in installation versus requirements.
11. Risk Assessment for Installation Qualification: Evaluation of installation-related risks.
12. Approved SOP: Finalized and authorized operating procedures.
13. Layout Diagram: Detailed equipment placement within the facility.
14. Machine Diagram: Technical illustration of machine components and functions.
15. Vendor Calibration: Certification of calibration by the equipment supplier.
16. Material of Construction (MOC) Certificates: Documentation confirming materials meet standards.
17. Operational Qualification (OQ): Confirmation of equipment performance to specifications, with training.
18. Gap Assessments for Operational Qualification: Identification of performance deviations.
19. Risk Assessment for Operational Qualification: Assessment of operational risks, emphasizing safety protocols.
20. Picture Attachments: Visual documentation of installation and operation.
21. HMI and PLC Validation Report: Validation of Human-Machine Interface and Programmable Logic Controller compliance.
22. In-House Calibration: Routine calibration by company personnel.
23. Preventive Maintenance Copy: Scheduled maintenance to optimize equipment performance.
24. Performance Qualification (PQ): Assurance of consistent equipment performance, with training and quality control.
25. Risk Assessment for Performance Qualification: Identification and mitigation of performance-related risks.
26. Gap Assessments for Performance Qualification: Analysis of performance deviations and their implications.
27. Recommendations: Guidelines on equipment operation range and capacity.
28. Closure Report: Comprehensive summary of qualification process and equipment readiness.
29. Annual Calibration & Report: Yearly calibration and performance evaluation.
30. Requalification: Periodic reassessment every 2-5 years to maintain qualification.
31. Deviation Records: Documentation of operational deviations.

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