Design Qualification Protocol for Cartridge Stoppering Machine
Document Control:
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed by: [Insert Name]
Approval Date: [Insert Date]
Objective
The purpose of this Design Qualification (DQ) protocol is to verify that the Cartridge Stoppering Machine is designed to meet the specified requirements for inserting stoppers into cartridges, ensuring compliance with regulatory standards and product quality.
Scope
This protocol applies to the validation of the Cartridge Stoppering Machine used in the production area for prefilled syringes and cartridges. It covers the critical parameters that impact product quality and compliance.
Responsibilities
The Validation Team is responsible for executing the DQ protocol, documenting results, and ensuring compliance with the Acceptance Criteria as per URS Annex 11.
Prerequisites
All necessary documentation, including User Requirements Specifications (URS), Functional Specifications, and design documents, must be available prior to executing this protocol.
Equipment Description
The Cartridge Stoppering Machine is designed to automatically insert stoppers into cartridges. It utilizes advanced technology to ensure accurate stopper placement and includes features for reject logic and audit trail logging.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-01 | Verify stopper placement reject logic | Reject logic functions correctly | Audit trail logs |
| DQ-02 | Check audit trail logging | Logs are complete and accessible | Log review report |
Detailed Test Cases
Test Case DQ-01: Verify Stopper Placement Reject Logic
Procedure: Run the machine with a known defective stopper. Verify that the reject logic activates and logs the event.
Acceptance Criteria: The machine must reject the defective stopper and log the event in the audit trail.
Test Case DQ-02: Check Audit Trail Logging
Procedure: Review the audit trail logs after multiple runs of the machine.
Acceptance Criteria: All events should be logged with timestamps and operator IDs.
Deviations
Any deviations from the defined procedures or acceptance criteria must be documented and investigated. A deviation report should be created detailing the nature of the deviation and corrective actions taken.
Approvals
This protocol must be reviewed and approved by the Validation Manager and Quality Assurance before execution.
Data Integrity Checks
1. Ensure that all audit trails are timestamped and tamper-proof.
2. Regularly back up audit trail logs to prevent data loss.
3. Implement access controls to restrict unauthorized changes to the system.