Validation Summary Report

Equipment: Fitz Mill / Comminuting Mill

Subcategory: Solid Dosage Form (OSD)

Area: Production/Milling

Summary

This Validation Summary Report (VSR) outlines the validation activities conducted for the Fitz Mill / Comminuting Mill used in the production of solid dosage forms. The report covers the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.

Scope/Boundaries

The scope of this validation includes the assessment of the Fitz Mill in the production area, focusing on the milling process for solid dosage forms. The boundaries of this validation encompass all operational aspects of the equipment as defined in the User Requirement Specification (URS).

Executed Protocol List

DQ Protocol: Fitz Mill DQ Report
IQ Protocol: Fitz Mill IQ Report
OQ Protocol: Fitz Mill OQ Report
PQ Protocol: Fitz Mill PQ Report

Deviations Summary

No significant deviations were noted during the validation process. All activities were performed in accordance with the approved protocols.

CPP Verification Summary

The key critical parameters verified during the qualification include:

Speed
Screen Size
Particle Size Distribution (PSD)

All parameters met the acceptance criteria as outlined in the URS.

Conclusion

The Fitz Mill / Comminuting Mill has been successfully validated for use in the production of solid dosage forms. All qualifications (DQ, IQ, OQ, PQ) have been completed, and the equipment is deemed suitable for its intended use.

Requalification Frequency

Requalification is scheduled every 24 months.

Attachments Index

Attachment 1: DQ Protocol
Attachment 2: IQ Protocol
Attachment 3: OQ Protocol
Attachment 4: PQ Protocol

Approvals

Report prepared by: [Name, Title]

Approved by: [Name, Title]