Installation Qualification Protocol for Nasal Spray Filling Machine
Document Control Number: IQ-NSFM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Nasal Spray Filling Machine is installed correctly and operates according to the specified requirements for the production of nasal spray bottles.
Scope
This protocol applies to the Nasal Spray Filling Machine located in the Production area, intended for filling nasal spray bottles with sterile and non-sterile products.
Responsibilities
The Validation Team is responsible for executing this protocol, while the Quality Assurance (QA) team will review and approve the results.
Prerequisites
- Installation of Nasal Spray Filling Machine completed.
- Training of personnel on machine operation.
- Availability of necessary documentation (URS, specifications, etc.).
Equipment Description
The Nasal Spray Filling Machine is designed for filling bottles with nasal spray solutions. It features automated filling mechanisms with built-in fill accuracy reject logic and an audit trail for traceability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-001 | Verify installation against manufacturer’s specifications. | All components installed as per specifications. | Installation checklist. |
| IQ-002 | Check electrical and mechanical connections. | No loose connections; all systems operational. | Inspection report. |
| IQ-003 | Perform fill accuracy test. | Fill accuracy within ± 5% of target volume. | Fill accuracy report. |
| IQ-004 | Validate reject logic functionality. | Reject logic activates for out-of-spec fills. | Audit trail log. |
Detailed Test Cases
Test Case: IQ-001
Procedure: Verify installation against manufacturer’s specifications by reviewing the installation checklist.
Acceptance Criteria: All components must be installed as per specifications.
Evidence: Installation checklist signed off by responsible personnel.
Test Case: IQ-002
Procedure: Check all electrical and mechanical connections for integrity.
Acceptance Criteria: No loose connections; all systems must be operational.
Evidence: Inspection report documenting the status of connections.
Test Case: IQ-003
Procedure: Conduct a fill accuracy test using calibrated measuring devices.
Acceptance Criteria: Fill accuracy must be within ± 5% of target volume.
Evidence: Fill accuracy report detailing the results of the test.
Test Case: IQ-004
Procedure: Validate the reject logic by intentionally producing out-of-spec fills.
Acceptance Criteria: The reject logic must activate for any out-of-spec fills.
Evidence: Audit trail log demonstrating reject logic functionality.
Deviations
Any deviations from the acceptance criteria must be documented and addressed through a formal deviation report. Corrective actions should be implemented as needed.
Approvals
The results of this Installation Qualification will be reviewed and approved by the QA team before the equipment can be used for production.