Design Qualification Protocol for Case Packer in IV Infusions

Objective

The objective of this Design Qualification (DQ) protocol is to ensure that the Case Packer used in the packaging of IV Infusions (LVP/SVP – Bags/Bottles) meets the specified requirements and operates according to the intended use, ensuring product integrity and compliance with regulatory standards.

Scope

This protocol applies to the Case Packer within the Packaging/Secondary area, focusing on its use to pack cartons into shippers for IV Infusions. The product impact is classified as indirect, with a criticality level of major.

Responsibilities

The following personnel are responsible for the execution and approval of this protocol:

• Validation Lead: Responsible for overseeing the validation process.
• Quality Assurance: Ensures compliance with regulatory requirements.
• Operations: Executes the DQ protocol and provides necessary documentation.

Prerequisites

Before executing this DQ protocol, the following must be completed:

• Installation Qualification (IQ) of the Case Packer.
• Operational Qualification (OQ) of the Case Packer.
• Review of User Requirements Specification (URS) Annex11.

Equipment Description

The Case Packer is designed to efficiently pack cartons into shippers for IV Infusions. It is equipped with features to ensure pack integrity and includes an audit trail for tracking operations.

Test Plan

Detailed Test Cases

Test Case DQ-CP-01

Objective: To verify that the Case Packer maintains an accurate pack integrity audit trail.

Procedure: Execute a series of packing operations and review the generated audit trail logs.

Acceptance Criteria: The audit trail logs all packing operations in accordance with URS Annex11.

Expected Outcome: Audit trail is complete and accurate.

Test Case DQ-CP-02

Objective: To evaluate the packing speed and accuracy of the Case Packer.

Procedure: Conduct a series of packing runs and measure speed and accuracy.

Acceptance Criteria: Packing speed meets specified limits and accuracy is greater than 98%.

Expected Outcome: Performance metrics are within acceptable limits.

Deviations

Any deviations from the protocol must be documented and assessed for impact on validation. A deviation report should be created and approved by Quality Assurance.

Approvals

This protocol must be approved by the following individuals:

• Validation Lead: ____________________ Date: ___________
• Quality Assurance: ____________________ Date: ___________
• Operations Manager: ____________________ Date: ___________

Data Integrity Checks

As CSV is required, the following data integrity checks will be implemented:

• Validation of data entry during packing operations.
• Audit trail review to confirm all operations are logged.
• Regular backup of audit trail data to ensure no loss of information.