Validation Summary Report (VSR)

Summary

This report summarizes the validation activities performed for the Coding Machine (Laser/Inkjet) used in the packaging of Transdermal Patches (TDS). The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). All qualifications have been successfully completed in accordance with the acceptance criteria outlined in URS Annex11.

Scope and Boundaries

The scope of this validation includes the Coding Machine utilized in the packaging area for Transdermal Patches. The boundaries are defined to encompass all relevant processes, equipment, and personnel involved in the operation of the coding machine during packaging operations.

Executed Protocol List

• DQ Protocol – Coding Machine (Laser/Inkjet)
• IQ Protocol – Coding Machine (Laser/Inkjet)
• OQ Protocol – Coding Machine (Laser/Inkjet)
• PQ Protocol – Coding Machine (Laser/Inkjet)

Deviations Summary

No deviations were noted during the validation process. All testing and documentation adhered to the established protocols and acceptance criteria.

CPP Verification Summary

The key critical parameter verified was the print quality audit trail logs. The audit trail logs demonstrated compliance with established specifications, ensuring the integrity and quality of the printed information on the transdermal patches.

Conclusion

The validation of the Coding Machine (Laser/Inkjet) for Transdermal Patches packaging has been successfully completed. All qualifications (DQ, IQ, OQ, PQ) have met the acceptance criteria as per URS Annex11, and the equipment is deemed suitable for its intended use.

Attachments Index

• Attachment 1: DQ Protocol Report
• Attachment 2: IQ Protocol Report
• Attachment 3: OQ Protocol Report
• Attachment 4: PQ Protocol Report
• Attachment 5: Print Quality Audit Trail Logs

Approvals

The following personnel have reviewed and approved this Validation Summary Report:

• _________________________ (Quality Assurance)
• _________________________ (Validation Manager)
• _________________________ (Operations Manager)