Validation Summary Report (VSR)
Equipment: Bottle Unscrambler
Subcategory: Solid Dosage Form (OSD)
Area: Packaging/Primary
Summary
This Validation Summary Report (VSR) outlines the validation activities conducted for the Bottle Unscrambler used in the packaging of solid dosage forms. The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, all of which have been completed successfully.
Scope/Boundaries
The scope of this validation encompasses the Bottle Unscrambler within the packaging area for solid dosage forms. The validation activities are limited to the equipment’s operation, performance, and integration into the existing packaging line.
Executed Protocol List
- DQ Protocol: Bottle Unscrambler Design Qualification
- IQ Protocol: Bottle Unscrambler Installation Qualification
- OQ Protocol: Bottle Unscrambler Operational Qualification
- PQ Protocol: Bottle Unscrambler Performance Qualification
Deviations Summary
No deviations were noted during the validation process. All protocols were executed as per the approved plans and specifications.
CPP Verification Summary
The key critical parameters verified during the validation include:
- Speed: Confirmed to be within specified limits.
- Jam Sensors: Functionality tested and confirmed operational.
- Interlocks: Verified to ensure safety and compliance.
Conclusion
Based on the executed validation protocols, the Bottle Unscrambler is deemed qualified for use in the packaging of solid dosage forms. The equipment meets the acceptance criteria as outlined in the User Requirement Specification (URS).
Requalification Frequency
The Bottle Unscrambler will be subject to requalification every 24 months to ensure continued compliance and performance.
Attachments Index
- Attachment 1: DQ Protocol Document
- Attachment 2: IQ Protocol Document
- Attachment 3: OQ Protocol Document
- Attachment 4: PQ Protocol Document
- Attachment 5: User Requirement Specification (URS)
Approvals
This report has been reviewed and approved by the following individuals:
- Validated by: [Name, Title, Date]
- Approved by: [Name, Title, Date]