Validation Summary Report (VSR)
Equipment Information
Equipment: Hammer Mill
Subcategory: Solid Dosage Form (OSD)
Area: Production/Milling
DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes
Acceptance Criteria Reference: URS
Summary
This Validation Summary Report outlines the validation activities conducted for the Hammer Mill used in the production of solid dosage forms. The report includes the executed protocols, deviations, and critical parameter verifications.
Scope/Boundaries
The scope of this validation covers the installation, operational, and performance qualifications of the Hammer Mill within the production area. It includes all relevant processes and equipment used in conjunction with the Hammer Mill.
Executed Protocol List
- DQ Protocol
- IQ Protocol
- OQ Protocol
- PQ Protocol
Deviations Summary
No significant deviations were noted during the validation process. All protocols were executed as per the approved plans.
CPP Verification Summary
The key critical parameters have been verified as follows:
- Speed: Verified against specifications.
- Screen Output: Confirmed to meet acceptance criteria.
- Particle Size Distribution (PSD): Consistent with URS requirements.
- Heat: Monitored and within acceptable limits.
Conclusion
Based on the executed protocols and the verification of critical parameters, the Hammer Mill is deemed qualified for use in the production of solid dosage forms. The requalification frequency is established at 24 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: Raw Data and Results
Approvals
Validated by: ____________________
Date: ____________________