Document Control
Document ID: PQ-PSFM-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Performance Qualification Protocol for Prefilled Syringe Filling Machine
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Prefilled Syringe Filling Machine operates consistently and reliably within established limits for filling sterile drugs into syringes, ensuring compliance with regulatory standards.
Scope
This protocol applies to the validation of the Prefilled Syringe Filling Machine located in the Production area. It encompasses the processes involved in filling sterile drug products into prefilled syringes, with a focus on critical parameters and compliance with URS Annex 1 and Annex 11.
Responsibilities
The responsibilities for this protocol are as follows:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Team: Responsible for providing operational support during the PQ execution.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary documentation including User Requirements Specification (URS) and Standard Operating Procedures (SOPs).
- Training of personnel on the operation of the Prefilled Syringe Filling Machine.
Equipment Description
The Prefilled Syringe Filling Machine is designed for the automated filling of sterile drugs into prefilled syringes. It is equipped with features to ensure fill accuracy, reject logic, and audit trail logs, which are critical for maintaining product integrity and compliance.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify fill accuracy | Fill accuracy within ±5% of target volume | Calibration logs, measurement records |
| PQ-02 | Audit reject logic functionality | Reject logic activates for out-of-spec fills | System logs, incident reports |
| PQ-03 | Review audit trail logs | All logs must be complete and retrievable | Audit trail report |
Detailed Test Cases
Test ID: PQ-01
Procedure: Conduct fill accuracy tests using calibrated measuring equipment. Fill a minimum of 30 syringes and measure the volume.
Acceptance Criteria: The fill volume must be within ±5% of the target volume.
Evidence: Documented measurement results and calibration logs.
Test ID: PQ-02
Procedure: Simulate out-of-spec fill conditions and verify that the reject logic activates appropriately.
Acceptance Criteria: The machine must reject any syringe that does not meet the fill accuracy specifications.
Evidence: System logs and incident reports documenting the reject actions.
Test ID: PQ-03
Procedure: Review and retrieve audit trail logs from the machine’s software to ensure compliance.
Acceptance Criteria: All logs must be complete, with no missing entries.
Evidence: Audit trail report showing log completeness and integrity.
Deviations
Any deviations from the established acceptance criteria must be documented and investigated. A deviation report should be generated to assess the impact on product quality and compliance.
Approvals
By signing below, the following individuals approve this Performance Qualification Protocol:
Prepared by: _______________________ Date: ___________
Reviewed by: _______________________ Date: ___________
Approved by: _______________________ Date: ___________
Data Integrity Checks
As CSV is required, the following practical data integrity checks will be performed:
- Verification of user access controls and permissions to ensure only authorized personnel can access critical system functions.
- Regular backups of audit trail logs to prevent data loss.
- Validation of data entry processes to ensure accuracy and completeness.