Document Control Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Performance Qualification Protocol for Coding Machine in Equipment Validation
Meta Description: This document outlines the Performance Qualification Protocol for the Coding Machine used in the packaging of suppositories and implants, ensuring compliance with URS Annex 11.
Tags: Equipment Validation, Performance Qualification, Coding Machine, Packaging, Regulatory Compliance
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Coding Machine (Inkjet / Laser) used for printing batch and expiry details on packaging for suppositories and implants, ensuring that it meets regulatory compliance and operational requirements.
Scope
This protocol applies to the Coding Machine utilized in the packaging area for the direct impact on product quality and compliance, specifically for suppositories and implants.
Responsibilities
The following personnel are responsible for the execution and oversight of this protocol:
- Validation Engineer: Responsible for protocol execution and documentation.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Supervisor: Responsible for ensuring that the equipment is operated in accordance with this protocol.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary materials and equipment for testing.
- Training of personnel on the operation of the Coding Machine.
Equipment Description
The Coding Machine (Inkjet / Laser) is designed to print batch and expiry details on packaging materials for suppositories and implants. It operates within specified parameters to ensure print quality and accuracy.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Perform print quality audit trail log review. | Logs must demonstrate compliance with print quality standards. | Audit trail log report. |
| PQ-02 | Verify print clarity and legibility. | Print must be clear and legible as per specifications. | Visual inspection report. |
| PQ-03 | Conduct data integrity checks on printed information. | No discrepancies between printed and system data. | Data comparison report. |
Detailed Test Cases
Test Case: PQ-01
Objective: To ensure that the print quality audit trail logs are maintained accurately.
Procedure: Review the audit trail logs for the last 30 production runs.
Expected Result: All logs should be complete and free from errors.
Test Case: PQ-02
Objective: To verify the clarity and legibility of printed information.
Procedure: Inspect at least 10 printed packages for clarity and legibility.
Expected Result: All printed information must be clear and legible.
Test Case: PQ-03
Objective: To confirm data integrity between printed information and system records.
Procedure: Compare printed batch and expiry details against the system records for accuracy.
Expected Result: No discrepancies should be found between printed and system data.
Deviations
Any deviations from the established acceptance criteria must be documented and investigated. A corrective action plan should be developed to address any identified issues.
Approvals
By signing below, the following individuals approve this Performance Qualification Protocol:
__________________________ Validation Engineer
__________________________ Quality Assurance
__________________________ Production Supervisor