Validation Summary Report (VSR)
Summary
This report outlines the validation activities performed for the Aseptic Filling Machine utilized in the production of IV Infusions (LVP/SVP – Bags/Bottles). The validation encompasses Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with the acceptance criteria outlined in URS Annex1 and Annex11.
Scope/Boundaries
The scope of this validation includes the Aseptic Filling Machine used for filling IV Bottles in the Production area. The boundaries of this validation encompass all critical parameters affecting the fill volume accuracy, stopper/cap placement, and reject audit trail.
Executed Protocol List
- Design Qualification (DQ) Protocol
- Installation Qualification (IQ) Protocol
- Operational Qualification (OQ) Protocol
- Performance Qualification (PQ) Protocol
Deviations Summary
No deviations were identified during the execution of the validation protocols. All activities were performed as per the approved protocols and acceptance criteria.
CPP Verification Summary
Key critical parameters were verified as follows:
- Fill Volume Accuracy: Compliant with defined specifications.
- Stopper/Cap Placement: Verified to meet established criteria.
- Reject Audit Trail: Successfully maintained and reviewed.
Conclusion
The Aseptic Filling Machine has successfully met all validation requirements as per DQ, IQ, OQ, and PQ protocols. The equipment is deemed qualified for use in the production of IV Infusions, with a requalification frequency established at 12 months.
Attachments Index
- Attachment 1: DQ Protocol Report
- Attachment 2: IQ Protocol Report
- Attachment 3: OQ Protocol Report
- Attachment 4: PQ Protocol Report
- Attachment 5: Validation Summary Report
Approvals
Approved by:
- ____________________ (Validation Manager)
- ____________________ (Quality Assurance)
- ____________________ (Production Manager)