Validation Summary Report
Equipment Information
Equipment: Coding Machine (Inkjet/Laser)
Subcategory: Nasal & Otic Products (Sterile / Non-Sterile)
Area: Packaging
DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes
Acceptance Criteria Reference: URS Annex11
Key Critical Parameters: Print quality audit trail logs
Requalification Frequency: 12 Months
Summary
This Validation Summary Report outlines the validation activities performed for the Coding Machine used in the packaging of Nasal and Otic products. The report includes details on the executed protocols and the compliance with established acceptance criteria.
Scope and Boundaries
The scope of this validation encompasses the installation, operational, and performance qualifications of the Coding Machine. The boundaries include all processes related to the packaging of Nasal and Otic products, both sterile and non-sterile.
Executed Protocol List
- Design Qualification (DQ) Protocol
- Installation Qualification (IQ) Protocol
- Operational Qualification (OQ) Protocol
- Performance Qualification (PQ) Protocol
Deviations Summary
No deviations were reported during the execution of the validation protocols. All activities were performed in accordance with the established procedures and acceptance criteria.
CPP Verification Summary
Critical Process Parameters (CPPs) were verified through comprehensive testing of print quality audit trail logs, ensuring compliance with the specifications outlined in the URS Annex11.
Conclusion
The validation of the Coding Machine (Inkjet/Laser) has been successfully completed. All protocols were executed as planned, with no deviations noted. The machine is deemed qualified for use in the packaging of Nasal and Otic products.
Attachments Index
- Attachment 1: DQ Protocol Document
- Attachment 2: IQ Protocol Document
- Attachment 3: OQ Protocol Document
- Attachment 4: PQ Protocol Document
Approvals
Prepared by: [Name]
Title: [Title]
Date: [Date]
Reviewed by: [Name]
Title: [Title]
Date: [Date]
Approved by: [Name]
Title: [Title]
Date: [Date]