Validation Summary Report (VSR)

Equipment: Multi Mill

Subcategory: Solid Dosage Form (OSD)

Area: Production/Milling

Summary

This Validation Summary Report outlines the validation activities conducted for the Multi Mill used in the production of solid dosage forms. The report encompasses all phases of validation, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Scope and Boundaries

The scope of this validation includes the Multi Mill’s operation within the production area for milling solid dosage forms. The boundaries are defined by the equipment’s operational limits and the applicable regulatory requirements.

Executed Protocol List

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

Deviations Summary

No deviations were reported during the validation of the Multi Mill. All protocols were executed as per the approved plans.

CPP Verification Summary

The following key critical parameters were verified and met the acceptance criteria as per the User Requirement Specification (URS):

Rotor Speed: Verified within acceptable limits.
Screen Integrity: Confirmed with no breaches.
Output Particle Size Distribution (PSD): Achieved as specified.

Conclusion

The Multi Mill has successfully passed all validation phases and is compliant with the established acceptance criteria. It is deemed suitable for its intended use in the production of solid dosage forms.

Requalification Frequency

The requalification of the Multi Mill is scheduled every 24 months.

Attachments Index

Attachment 1: DQ Protocol
Attachment 2: IQ Protocol
Attachment 3: OQ Protocol
Attachment 4: PQ Protocol
Attachment 5: URS Document

Approvals

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

Quality Assurance Manager: ____________________
Validation Manager: ____________________
Production Manager: ____________________