Validation Summary Report (VSR)
Summary
This Validation Summary Report outlines the validation activities performed for the Sterile Filtration Skid used in the production of prefilled syringes and cartridges. The report encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, confirming compliance with URS Annex 1 and Annex 11 acceptance criteria.
Scope/Boundaries
The scope of this validation encompasses the Sterile Filtration Skid utilized in the production area for prefilled syringes and cartridges. The boundaries include the equipment itself, associated software, and the operational environment in which the skid functions.
Executed Protocol List
- DQ Protocol: Sterile Filtration Skid DQ Report
- IQ Protocol: Sterile Filtration Skid IQ Report
- OQ Protocol: Sterile Filtration Skid OQ Report
- PQ Protocol: Sterile Filtration Skid PQ Report
Deviations Summary
No deviations were recorded during the validation process. All activities were executed in accordance with the established protocols and acceptance criteria.
CPP Verification Summary
Key critical parameters verified during the validation include:
- Flow rate
- Differential Pressure (DP)
- Integrity audit trail logs
All critical parameters were found to be within the defined acceptance criteria.
Conclusion
The validation activities for the Sterile Filtration Skid have been successfully completed, demonstrating that the equipment operates in compliance with the specified requirements and acceptance criteria. The equipment is deemed suitable for its intended use in the production of prefilled syringes and cartridges.
Attachments Index
- Attachment 1: DQ Report
- Attachment 2: IQ Report
- Attachment 3: OQ Report
- Attachment 4: PQ Report
Approvals
Prepared by: [Name]
Title: [Title]
Date: [Date]
Reviewed by: [Name]
Title: [Title]
Date: [Date]