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.

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:

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Validation Lead

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Quality Assurance