Operational Qualification Protocol for Suppository Blister Packing Machine
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Suppository Blister Packing Machine operates according to its intended use and meets the specified acceptance criteria as outlined in the User Requirements Specification (URS) Annex 11.
Scope
This protocol applies to the Operational Qualification of the Suppository Blister Packing Machine utilized in the Packaging area for packing suppositories into blister packs. The OQ will cover key critical parameters that impact product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with applicable regulations. Quality Assurance (QA) will review and approve the final report.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All personnel involved must be trained on the equipment operation and validation processes.
- All necessary materials and equipment must be available and in good condition.
Equipment Description
The Suppository Blister Packing Machine is designed for packing suppositories into blister packs, ensuring product integrity and compliance with regulatory requirements. It operates under controlled sealing temperature, pressure, and dwell time parameters.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-001 | Verify sealing temperature | Within specified range as per URS | Audit trail logs, temperature records |
| OQ-002 | Verify sealing pressure | Within specified range as per URS | Audit trail logs, pressure records |
| OQ-003 | Verify dwell time | Within specified range as per URS | Audit trail logs, dwell time records |
Detailed Test Cases
Test Case OQ-001: Verify Sealing Temperature
Procedure: Measure the sealing temperature during operation using calibrated thermocouples.
Acceptance Criteria: Temperature must be within the specified range as per URS.
Evidence: Documented temperature readings and audit trail logs.
Test Case OQ-002: Verify Sealing Pressure
Procedure: Measure sealing pressure using a calibrated pressure gauge.
Acceptance Criteria: Pressure must be within the specified range as per URS.
Evidence: Documented pressure readings and audit trail logs.
Test Case OQ-003: Verify Dwell Time
Procedure: Measure the dwell time during the sealing process using a stopwatch.
Acceptance Criteria: Dwell time must be within the specified range as per URS.
Evidence: Documented dwell time readings and audit trail logs.
Deviations
Any deviations from the acceptance criteria must be documented, along with the rationale and corrective actions taken. All deviations will require approval from QA.
Approvals
Prepared By: ______________________ Date: ____________
Approved By: ______________________ Date: ____________