Document Control Number: OQ-PSP-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Operational Qualification Protocol for Nasal Spray Pump Assembly Machine
Objective: To validate the operational performance of the Pump Assembly Machine utilized in the assembly of nasal spray pumps, ensuring compliance with defined acceptance criteria.
Scope: This protocol applies to the Pump Assembly Machine used in the production area for the assembly of nasal spray pumps, both sterile and non-sterile, impacting product quality directly.
Responsibilities:
- Validation Team: Develop and execute the OQ protocol.
- Production Team: Provide necessary resources and support during testing.
- Quality Assurance: Review and approve the OQ protocol and results.
Prerequisites:
- Installation Qualification (IQ) completed and approved.
- Staff trained on equipment operation and safety procedures.
Equipment Description:
The Pump Assembly Machine is designed for the assembly of nasal spray pumps, featuring mechanisms for precision placement and alignment. The critical parameters for this machine include placement alignment, reject logic, and audit trail functionality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify placement alignment accuracy. | Placement alignment within ±0.5 mm. | Calibration records, alignment test results. |
| OQ-002 | Test reject logic functionality. | Reject logic activates for misaligned pumps. | Test run results, system logs. |
| OQ-003 | Audit trail verification. | Audit trail records all operations accurately. | Audit trail reports, system logs. |
Detailed Test Cases:
- Test Case OQ-001: Conduct placement alignment test using calibrated measuring tools. Document results and confirm alignment accuracy.
- Test Case OQ-002: Perform a series of tests to intentionally misalign pumps and confirm that the reject logic activates as expected.
- Test Case OQ-003: Review audit trail logs after a complete production run to ensure all actions are recorded and retrievable.
Deviations: Any deviations from the acceptance criteria must be documented, including the nature of the deviation, investigation, and corrective actions taken.
Approvals:
- ____________________ (Validation Team Lead)
- ____________________ (Production Manager)
- ____________________ (Quality Assurance Manager)
Data Integrity Checks: Ensure that all data captured during the OQ process is securely stored, with access controls in place to prevent unauthorized modifications. Regular backups should be performed to maintain data integrity.