Validation Summary Report (VSR)

Equipment:

Flake Crusher (Post-Roller Compaction)

Subcategory:

Solid Dosage Form (OSD)

Area:

Production/Dry Granulation

DQ/IQ/OQ/PQ Flags:

Yes / Yes / Yes / Yes

Acceptance Criteria Reference:

URS

Key Critical Parameters:

Speed screen output PSD

Requalification Frequency:

24 Months

Summary:

This Validation Summary Report outlines the validation activities performed for the Flake Crusher utilized in the production of solid dosage forms through dry granulation. The report summarizes the executed protocols, deviations, and critical parameter verifications.

Scope/Boundaries:

The scope of this validation encompasses the installation, operational, and performance qualifications of the Flake Crusher, ensuring compliance with defined acceptance criteria.

Executed Protocol List:

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

Deviations Summary:

No significant deviations were noted during the validation process. All protocols were executed as per the approved plans, and all acceptance criteria were met.

CPP Verification Summary:

Critical Process Parameters (CPP) were verified, including speed and screen output Particle Size Distribution (PSD). All parameters were within specified limits as per the URS.

Conclusion:

The Flake Crusher has been successfully validated for use in the production of solid dosage forms. All qualification protocols have been executed and acceptance criteria met, ensuring compliance with regulatory requirements.

Attachments Index:

• Attachment 1: DQ Protocol
• Attachment 2: IQ Protocol
• Attachment 3: OQ Protocol
• Attachment 4: PQ Protocol
• Attachment 5: URS Document

Approvals:

_________________________
Validation Manager

_________________________
Quality Assurance