Operational Qualification Protocol for Sterile Powder Filling Machine
Document Control Number: OQ-SPFM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Sterile Powder Filling Machine operates within predetermined specifications and is capable of consistently filling sterile solutions into vials prior to lyophilization.
Scope
This protocol applies to the Sterile Powder Filling Machine utilized in the Production area for the filling of sterile solutions into vials. The OQ will ensure that the equipment meets the necessary operational requirements as outlined in the User Requirement Specification (URS) Annex 1 and Annex 11.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ documentation.
- Production Team: Responsible for ensuring the equipment is maintained and calibrated prior to OQ execution.
Prerequisites
- Equipment must be installed and calibrated.
- Operators must be trained in the operation of the Sterile Powder Filling Machine.
- All relevant SOPs must be available and adhered to.
Equipment Description
The Sterile Powder Filling Machine is designed to fill sterile solutions into vials with a focus on maintaining sterility and accuracy. The equipment includes features for fill accuracy reject logic and an audit trail for data integrity.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-001 | Verify fill accuracy with standard solution. | Fill accuracy within ± 0.5% of target volume. | Calibration report, filled vials data. |
| OQ-002 | Test reject logic functionality. | Reject logic activates on out-of-spec fill. | Audit trail report. |
| OQ-003 | Verify audit trail functionality. | Audit trail logs all operations accurately. | Audit trail report. |
Detailed Test Cases
Test Case OQ-001: Fill Accuracy
Procedure: Fill vials with a standard solution and measure the volume filled. Record the data.
Acceptance Criteria: Fill accuracy must be within ± 0.5% of the target volume.
Evidence: Calibration report and filled vials data must be documented and reviewed.
Test Case OQ-002: Reject Logic Functionality
Procedure: Simulate out-of-spec fill conditions and verify that the reject logic activates.
Acceptance Criteria: The machine must reject any vial that is out of specification.
Evidence: Audit trail report documenting the rejection events.
Test Case OQ-003: Audit Trail Functionality
Procedure: Review the audit trail after performing several filling operations.
Acceptance Criteria: The audit trail must accurately log all operations performed on the machine.
Evidence: Audit trail report must be provided for review.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan must be developed if deviations occur.
Approvals
Prepared by: [Name], Validation Team
Reviewed by: [Name], Quality Assurance
Approved by: [Name], Production Manager