Performance Qualification Protocol for Coding Machine Used in Transdermal Patch Production
Document Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared By: [Name]
Approved By: [Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to demonstrate that the Coding Machine (Laser/Inkjet) used in the packaging of Transdermal Patches consistently performs as intended, ensuring accurate printing of batch and expiry details.
Scope
This protocol applies to the Coding Machine utilized in the packaging area for Transdermal Patches, directly impacting product quality and compliance with regulatory standards.
Responsibilities
The Validation Team is responsible for executing the PQ protocol and documenting results. Quality Assurance will review and approve the final report.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary documentation, including User Requirement Specifications (URS) and Annex 11 guidelines.
- Training of personnel on the operation of the Coding Machine.
Equipment Description
The Coding Machine (Laser/Inkjet) is designed to print batch and expiry details on Transdermal Patches. It features high-resolution printing capabilities and an integrated audit trail log system for maintaining print quality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001-01 | Verify print quality by conducting a visual inspection and audit trail log review. | Print quality meets specifications as defined in URS Annex 11. | Inspection report and audit trail logs. |
| PQ-001-02 | Perform a print test on a sample batch. | Batch and expiry details are printed accurately without errors. | Sample printouts and test results. |
Detailed Test Cases
Test Case: PQ-001-01
Objective: To ensure that the print quality meets the required standards.
Steps:
- Conduct a visual inspection of printed labels.
- Review the audit trail logs for discrepancies.
Expected Result: All printed labels should be clear and legible, and audit logs should show no errors.
Test Case: PQ-001-02
Objective: To verify the accuracy of printed batch and expiry details.
Steps:
- Print a sample batch using the Coding Machine.
- Compare printed details with the batch record.
Expected Result: Printed details match the batch record without discrepancies.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed. A root cause analysis should be performed, and corrective actions implemented as necessary.
Approvals
This protocol must be approved by the Quality Assurance team prior to execution. All results must be reviewed and approved in the final report.
Data Integrity Checks
- Ensure that all print quality audit trail logs are securely stored and accessible only to authorized personnel.
- Implement regular backups of electronic records related to printing operations.
- Conduct periodic reviews of print quality logs to identify any anomalies.