Validation Summary Report

Equipment: Capsule Filling Machine (Automatic)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Capsules

Summary

This Validation Summary Report (VSR) outlines the validation activities performed on the Capsule Filling Machine (Automatic) in accordance with the requirements set forth in the User Requirement Specification (URS) Annex 11. The machine has been validated for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Scope/Boundaries

The scope of this validation encompasses the installation, operation, and performance of the Capsule Filling Machine within the Production/Capsules area. It includes the evaluation of key critical parameters such as fill weight, speed, rejects, and PLC functionality.

Executed Protocol List

DQ Protocol – Capsule Filling Machine
IQ Protocol – Capsule Filling Machine
OQ Protocol – Capsule Filling Machine
PQ Protocol – Capsule Filling Machine

Deviations Summary

No deviations were noted during the validation process. All protocols were executed as per the approved plans.

CPP Verification Summary

The following critical parameters were verified during the validation process:

Fill Weight: Confirmed within specified limits.
Speed: Verified against operational standards.
Rejects: Monitored and maintained below acceptable thresholds.
PLC: Functionality confirmed through rigorous testing.

Conclusion

The Capsule Filling Machine (Automatic) has successfully met all validation criteria as outlined in the URS Annex 11. It is recommended for routine use in production, with a requalification frequency of 12 months.

Attachments Index

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

Approvals

Prepared by: ____________________ Date: ___________

Reviewed by: ____________________ Date: ___________

Approved by: ____________________ Date: ___________