Validation Summary Report (VSR)

Summary

This report summarizes the validation activities conducted for the Co-Mill / Conical Mill used in the production of solid dosage forms (OSD). The validation process included Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Scope and Boundaries

The scope of this validation encompasses the Co-Mill / Conical Mill utilized in the milling process within the production area. The boundaries include the equipment setup, operation procedures, and performance metrics as outlined in the User Requirements Specification (URS).

Executed Protocol List

• DQ Protocol – Co-Mill / Conical Mill
• IQ Protocol – Co-Mill / Conical Mill
• OQ Protocol – Co-Mill / Conical Mill
• PQ Protocol – Co-Mill / Conical Mill

Deviations Summary

No deviations were noted during the execution of the validation protocols. All activities were completed in accordance with the established procedures and acceptance criteria.

CPP Verification Summary

The following key critical parameters were verified during the validation process:

• Impeller Speed
• Screen Size
• Output Particle Size Distribution (PSD)

All parameters met the acceptance criteria defined in the URS.

Conclusion

The Co-Mill / Conical Mill has been successfully validated for use in the production of solid dosage forms. All qualifications (DQ, IQ, OQ, PQ) were completed with no deviations, and the critical parameters were verified against the acceptance criteria.

Attachments Index

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

Approvals

Prepared by: ______________________

Date: ______________________

Approved by: ______________________

Date: ______________________