Validation Summary Report (VSR)

1. Summary

This Validation Summary Report (VSR) outlines the validation activities performed for the Suppository Molding Machine, ensuring compliance with regulatory requirements and internal standards.

2. Scope and Boundaries

The scope of this validation encompasses the installation, operational, and performance qualification of the Suppository Molding Machine used in the production area for suppositories and implants. The boundaries include all relevant processes and equipment associated with the machine.

3. Executed Protocol List

• DQ Protocol – Design Qualification
• IQ Protocol – Installation Qualification
• OQ Protocol – Operational Qualification
• PQ Protocol – Performance Qualification

4. Deviations Summary

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

5. CPP Verification Summary

Key Critical Parameters (CPP) were verified as follows:

• Fill Volume: Verified against acceptance criteria.
• Mold Temperature: Monitored and recorded.
• Cooling: Assessed for consistency and reliability.
• PLC Logs: Reviewed for accuracy and compliance.
• Audit Trail: Confirmed to be intact and complete.

6. Conclusion

The validation of the Suppository Molding Machine has been successfully completed in accordance with URS Annex 11 and Annex 15. The equipment is deemed qualified for use in production.

7. Attachments Index

• Attachment A: DQ Protocol
• Attachment B: IQ Protocol
• Attachment C: OQ Protocol
• Attachment D: PQ Protocol
• Attachment E: CPP Verification Data

8. Approvals

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Validation Manager

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Quality Assurance