Validation Summary Report (VSR)

Equipment

Equipment: Vacuum Transfer System (Central)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Material Transfer

Validation Flags

DQ: Yes

IQ: Yes

OQ: Yes

PQ: Yes

Acceptance Criteria Reference

Reference: URS Annex 11

Key Critical Parameters

Flow Rates
Filters
Valve Timing
PLC

Requalification Frequency

Frequency: 24 Months

Summary

This report summarizes the validation activities conducted for the Vacuum Transfer System (Central) utilized in the production of Solid Dosage Forms. The validation process included Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure compliance with regulatory requirements and operational standards.

Scope/Boundaries

The scope of this validation encompasses the Vacuum Transfer System and its components, including flow measurement devices, filters, valves, and the PLC system. Boundaries include the operational limits defined in the URS and the specific parameters evaluated during the validation process.

Executed Protocol List

DQ Protocol – Vacuum Transfer System
IQ Protocol – Vacuum Transfer System
OQ Protocol – Vacuum Transfer System
PQ Protocol – Vacuum Transfer System

Deviations Summary

No significant deviations were encountered during the validation process. All tests were performed as per the approved protocols and met the acceptance criteria specified in the URS Annex 11.

CPP Verification Summary

All critical process parameters (CPPs) were verified and validated according to the established acceptance criteria. The flow rates, filter integrity, valve timing, and PLC functionality were confirmed to be within acceptable limits, ensuring the system operates effectively and safely.

Conclusion

The validation of the Vacuum Transfer System (Central) has been successfully completed. The system has been demonstrated to meet all specified requirements and is deemed suitable for use in the production of Solid Dosage Forms.

Attachments Index

Attachment 1: DQ Protocol Document
Attachment 2: IQ Protocol Document
Attachment 3: OQ Protocol Document
Attachment 4: PQ Protocol Document
Attachment 5: Summary of Results

Approvals

Prepared by: [Name]

Title: [Title]

Date: [Date]

Approved by: [Name]