Document Control Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Performance Qualification Protocol for Safety Device Assembly Machine
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Safety Device Assembly Machine operates consistently and reliably within the specified parameters to ensure the correct assembly of safety devices on prefilled syringes and cartridges.
Scope
This protocol applies to the Safety Device Assembly Machine used in the production area for the assembly of safety devices onto prefilled syringes and cartridges. The PQ will validate the performance of the equipment in a production environment.
Responsibilities
The following personnel are responsible for the execution and oversight of this PQ protocol:
- Validation Manager: Overall responsibility for validation activities.
- Quality Assurance: Review and approval of the protocol and results.
- Production Personnel: Execution of the test cases as per the protocol.
- Maintenance Personnel: Ensure equipment is maintained and calibrated.
Prerequisites
- Equipment must be installed and calibrated according to the manufacturer’s specifications.
- All relevant Standard Operating Procedures (SOPs) must be in place and followed.
- Personnel must be trained on the use of the Safety Device Assembly Machine.
Equipment Description
The Safety Device Assembly Machine is designed for the automated assembly of safety devices onto prefilled syringes and cartridges. It includes features for assembly accuracy and generates audit trail logs for compliance and traceability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify assembly accuracy | Assembly accuracy audit trail logs must be within ±1% of the target. | Audit trail logs report |
| PQ-02 | Check equipment calibration | Calibration must be within specified limits as per the manufacturer’s guidelines. | Calibration certificate |
Detailed Test Cases
Test Case 1: Verify Assembly Accuracy
Procedure: Run a batch of 100 prefilled syringes with the safety device assembly machine. Record the assembly accuracy from the audit trail logs.
Acceptance Criteria: The assembly accuracy must be within ±1% of the target. If the accuracy exceeds this limit, a deviation must be recorded.
Test Case 2: Check Equipment Calibration
Procedure: Review the calibration records of the Safety Device Assembly Machine prior to the PQ execution.
Acceptance Criteria: The calibration must be within specified limits as per the manufacturer’s guidelines. Any discrepancies must be documented and resolved before proceeding.
Deviations
Any deviations from the acceptance criteria must be documented in the deviation log, including the nature of the deviation, root cause analysis, and corrective actions taken.
Approvals
Approved By: [Name] – Validation Manager
Approved By: [Name] – Quality Assurance