High Shear Granulator (HSG) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment: High Shear Granulator (HSG)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Granulation

Summary

This Validation Summary Report (VSR) documents the validation activities performed for the High Shear Granulator (HSG) used in the production of solid dosage forms. The equipment has undergone Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as per the requirements outlined in the URS Annex11.

Scope/Boundaries

The scope of this validation includes the High Shear Granulator (HSG) utilized in the granulation process within the production area. The validation encompasses all critical parameters including speed, time, torque, binder addition, and PLC functionality.

Executed Protocol List

  • Design Qualification (DQ) Protocol
  • Installation Qualification (IQ) Protocol
  • Operational Qualification (OQ) Protocol
  • Performance Qualification (PQ) Protocol

Deviations Summary

During the validation process, no significant deviations were noted that would impact the integrity of the validation activities or the performance of the High Shear Granulator (HSG).

CPP Verification Summary

Critical Process Parameters (CPPs) were verified as per the acceptance criteria defined in the URS Annex11. The following parameters were monitored and validated:

  • Speed: Verified within acceptable range
  • Time: Confirmed adherence to specified duration
  • Torque: Measured and validated
  • Binder Addition: Confirmed accurate dosing
  • PLC: Functionality tested and validated

Conclusion

The validation activities for the High Shear Granulator (HSG) have been successfully completed. All critical parameters have been verified, and the equipment meets the acceptance criteria as defined in the URS Annex11. The equipment is deemed qualified for use in the production of solid dosage forms.

See also  Strip Packing Machine – Deviation Impact Assessment

Requalification Frequency

The requalification of the High Shear Granulator (HSG) is scheduled every 24 months.

Attachments Index

  • Attachment 1: DQ Protocol
  • Attachment 2: IQ Protocol
  • Attachment 3: OQ Protocol
  • Attachment 4: PQ Protocol
  • Attachment 5: Validation Raw Data

Approvals

Approved by:

__________________________
Validation Lead

__________________________
Quality Assurance

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