Performance Qualification Protocol for Nasal Spray Filling Equipment
Document Number: PQ-NSFM-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approved By: [Approver Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Nasal Spray Filling Machine operates consistently and reliably to meet specified requirements for filling nasal spray bottles.
Scope
This protocol applies to the Nasal Spray Filling Machine used in the production area for filling sterile and non-sterile nasal spray products. It encompasses all activities related to the performance qualification of the equipment.
Responsibilities
The following personnel are responsible for the execution and approval of this protocol:
- Validation Team: Execute and document the qualification activities.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide operational support during testing.
Prerequisites
Before executing this PQ protocol, the following prerequisites must be met:
- Installation Qualification (IQ) and Operational Qualification (OQ) must be completed and approved.
- All necessary training for personnel operating the equipment must be completed.
- All relevant Standard Operating Procedures (SOPs) must be in place and accessible.
Equipment Description
The Nasal Spray Filling Machine is designed to accurately fill nasal spray bottles with a specified volume of product. The equipment features include:
- Automated filling mechanism
- Fill accuracy reject logic
- Audit trail capabilities
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify fill accuracy | Fill volume within ± 5% of target | Calibration records, filled bottle measurements |
| PQ-02 | Test reject logic | Reject logic activates for out-of-spec fills | Audit trail log |
| PQ-03 | Audit trail verification | Audit trail must record all critical actions | Audit trail report |
Detailed Test Cases
Test Case 1: Verify Fill Accuracy
Objective: To confirm that the filling machine meets the specified fill volume criteria.
- Prepare the nasal spray bottles and set the target fill volume.
- Run the machine for a defined number of cycles.
- Measure the filled volume of each bottle using calibrated equipment.
- Document the results and assess against acceptance criteria.
Test Case 2: Test Reject Logic
Objective: To ensure that the reject logic functions correctly during filling.
- Configure the machine to simulate a fill volume outside the acceptance range.
- Run the filling process and observe if the reject logic activates.
- Document the activation and verify against the expected behavior.
Test Case 3: Audit Trail Verification
Objective: To confirm that all critical actions are logged by the audit trail.
- Conduct a series of filling operations.
- Access the audit trail and review entries for completeness.
- Document findings and ensure all critical actions are recorded.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A root cause analysis should be performed, and corrective actions should be defined.
Approvals
By signing below, the undersigned confirm that they have reviewed and approve this Performance Qualification Protocol.
____________________ [Reviewer Name] – Validation Team
____________________ [Approver Name] – Quality Assurance