Validation Summary Report (VSR)

Equipment: Inline Sterile Filtration Skid

Subcategory: Sterile Powders & Lyophilized Products

Area: Production

DQ/IQ/OQ/PQ Flags

Design Qualification (DQ): Yes

Installation Qualification (IQ): Yes

Operational Qualification (OQ): Yes

Performance Qualification (PQ): Yes

Acceptance Criteria Reference

URS Annex1 Annex11

Key Critical Parameters

Flow DP integrity audit trail logs

Requalification Frequency

12 Months

Summary

This Validation Summary Report outlines the validation activities performed for the Inline Sterile Filtration Skid, including the qualification phases and the results obtained. The equipment is intended for use in the production of sterile powders and lyophilized products, ensuring compliance with regulatory requirements.

Scope/Boundaries

The scope of this validation encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Inline Sterile Filtration Skid. The boundaries include all associated systems and processes necessary for its operation within the production area.

Executed Protocol List

Protocol for Design Qualification (DQ)
Protocol for Installation Qualification (IQ)
Protocol for Operational Qualification (OQ)
Protocol for Performance Qualification (PQ)

Deviations Summary

No deviations were noted during the qualification phases. All tests were performed in accordance with established protocols and acceptance criteria.

CPP Verification Summary

Critical Process Parameters (CPPs) were verified during the OQ phase, confirming that the Inline Sterile Filtration Skid functions within the specified limits. The key parameters, including flow rate and integrity audit trail logs, met predefined acceptance criteria.

Conclusion

The validation activities for the Inline Sterile Filtration Skid have been successfully completed. The equipment has been demonstrated to operate within the defined specifications and is suitable for its intended use in the production of sterile powders and lyophilized products.

Attachments Index

Attachment 1: DQ Protocol Document
Attachment 2: IQ Protocol Document
Attachment 3: OQ Protocol Document
Attachment 4: PQ Protocol Document
Attachment 5: Audit Trail Logs

Approvals

This report has been reviewed and approved by the following individuals:

Name: ____________________ | Title: ____________________ | Date: ____________________
Name: ____________________ | Title: ____________________ | Date: ____________________