Document Control Number: PQ-CP-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Case Packer in IV Infusions Packaging
Meta Description: This document outlines the Performance Qualification Protocol for the Case Packer equipment used in the packaging of IV Infusions, ensuring compliance with URS Annex11 acceptance criteria.
Tags: Equipment Validation, Performance Qualification, Case Packer, IV Infusions
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Case Packer operates according to predefined specifications and consistently produces a pack integrity audit trail for IV Infusions (LVP/SVP – Bags/Bottles).
Scope
This protocol applies to the Case Packer located in the Packaging/Secondary area, focusing on the packing of cartons into shippers. The impact on product quality is indirect, with a criticality rating of major.
Responsibilities
- Validation Team: Responsible for the execution of the PQ protocol and documentation of results.
- Quality Assurance: Responsible for reviewing and approving the PQ documentation.
- Equipment Operators: Responsible for operating the Case Packer during the validation process.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary materials for testing.
- Training of personnel on equipment operation and safety protocols.
Equipment Description
The Case Packer is designed to efficiently pack cartons of IV Infusions into shippers, ensuring that each carton is securely packed to maintain product integrity during transport.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-01 | Conduct a pack integrity audit trail. | Audit trail must show 100% integrity for all packs. | Audit trail report. |
| TP-02 | Verify packing speed. | Packing speed must meet URS specifications. | Packing speed log. |
Detailed Test Cases
Test Case 1: Pack Integrity Audit Trail
Objective: To ensure that the Case Packer provides a complete audit trail for pack integrity.
Procedure: Run the Case Packer with a batch of cartons and record the audit trail data.
Expected Result: The audit trail should document every pack with timestamps and operator IDs.
Test Case 2: Packing Speed Verification
Objective: To verify that the packing speed of the Case Packer meets the required specifications.
Procedure: Measure the time taken to pack a defined number of cartons and calculate the packing speed.
Expected Result: The packing speed should be within the specified limits as per the URS.
Deviations
All deviations from the protocol must be documented and justified. Any significant deviations must be reported to Quality Assurance for review.
Approvals
Prepared by: ____________________ (Validation Team Lead)
Reviewed by: ____________________ (Quality Assurance)
Approved by: ____________________ (Department Head)
Data Integrity Checks
Ensure that all data generated during the PQ is securely stored and backed up. Conduct regular audits of data logs to confirm accuracy and compliance with CSV requirements.