Document Control
Document Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Performance Qualification Protocol for Capping Machine in IV Infusions
Meta Description: This document outlines the Performance Qualification (PQ) protocol for the capping machine used in IV infusions, ensuring compliance with critical parameters and acceptance criteria.
Tags: Equipment Validation, PQ, Capping Machine, IV Infusions
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the capping machine used for capping IV infusion bottles to ensure it operates within defined parameters and meets regulatory compliance.
Scope
This protocol applies to the capping machine (ROPP/Screw) used in the production area for the capping of IV infusion bags and bottles, impacting product quality directly.
Responsibilities
The following roles are responsible for the execution of this protocol:
- Validation Team: Preparation and execution of the PQ protocol.
- Production Team: Operation of the capping machine during the PQ.
- Quality Assurance: Review and approval of the PQ results.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the operation of the capping machine.
- Availability of all necessary materials and equipment.
Equipment Description
The capping machine is designed to securely cap IV infusion bottles using ROPP or screw caps. It is critical for maintaining product integrity and safety.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-001 | Verify torque range settings | Within specified limits | Torque measurement logs |
| PQ-002 | Audit trail review | No discrepancies found | Audit trail report |
Detailed Test Cases
Test Case 1: Torque Range Verification
Objective: To ensure the torque applied during capping is within the specified range.
Procedure: Use a calibrated torque meter to measure the torque applied to the caps during operation.
Acceptance Criteria: Torque must be within the specified range as defined in the User Requirement Specification (URS) Annex 11.
Evidence: Document torque measurements and confirm compliance.
Test Case 2: Audit Trail Review
Objective: To confirm the integrity of the audit trail generated by the capping machine.
Procedure: Review the audit trail logs for any discrepancies or unauthorized changes.
Acceptance Criteria: No discrepancies or unauthorized changes should be present.
Evidence: Provide a copy of the audit trail report for review.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be established if necessary.
Approvals
Approved by: ____________________
Date: ____________________