Validation Summary Report (VSR)
Summary
This Validation Summary Report outlines the validation activities performed for the Weighing Balance (Analytical/Platform) utilized in the API Manufacturing (Chemical Synthesis) area, specifically within Production/Dispensing. The report confirms that the equipment meets the specified requirements and is compliant with regulatory standards.
Scope and Boundaries
The scope of this validation includes the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Weighing Balance. The boundaries are defined to include all activities related to the calibration, verification, and qualification of the equipment within the specified area.
Executed Protocol List
- Design Qualification (DQ) Protocol
- Installation Qualification (IQ) Protocol
- Operational Qualification (OQ) Protocol
- Performance Qualification (PQ) Protocol
Deviations Summary
No deviations were noted during the execution of the validation protocols. All processes were conducted in accordance with the established procedures and protocols.
CPP Verification Summary
The key critical parameters verified during the qualification process include:
- Accuracy
- Repeatability
- Linearity
All parameters met the acceptance criteria as outlined in the URS SOP Calibration.
Conclusion
The Weighing Balance has been successfully validated for use in API Manufacturing (Chemical Synthesis) within the Production/Dispensing area. The equipment complies with all specified acceptance criteria and is deemed suitable for its intended use. Requalification is scheduled to occur every 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: Calibration Certificates
Approvals
Prepared by: ____________________ Date: ____________
Reviewed by: ____________________ Date: ____________
Approved by: ____________________ Date: ____________