Validation Summary Report (VSR)

Equipment: Parts Washer (GMP)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Cleaning

Summary

This Validation Summary Report outlines the validation activities conducted for the Parts Washer used in the GMP production of solid dosage forms. The report includes details on the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.

Scope/Boundaries

The scope of this validation encompasses the Parts Washer’s operation within the Production/Cleaning area, ensuring compliance with regulatory standards and internal quality requirements as specified in the User Requirement Specification (URS) Annex 11.

Executed Protocol List

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

Deviations Summary

No significant deviations were noted during the validation process. All procedures were executed as per the defined protocols.

CPP Verification Summary

The following critical parameters were verified during the validation process:

Wash Temperature
Wash Time
Pressure
Detergent Dosing
PLC Functionality

All parameters met the acceptance criteria defined in the URS Annex 11.

Conclusion

The Parts Washer has been successfully validated for use in the production of solid dosage forms. All critical parameters were verified and found to be within acceptable limits. The equipment is deemed suitable for its intended use.

Attachments Index

Appendix A: DQ Protocol
Appendix B: IQ Protocol
Appendix C: OQ Protocol
Appendix D: PQ Protocol
Appendix E: Validation Summary Data

Approvals

Prepared by: [Name], [Title]

Reviewed by: [Name], [Title]

Approved by: [Name], [Title]

Requalification Frequency

Requalification is scheduled every 24 months.