Operational Qualification Protocol for Thermoform Blister Packing Machine
Document Number: OQ-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 Blister Packing Machine (Thermoform) operates within specified parameters and meets the requirements outlined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Operational Qualification of the Blister Packing Machine used in the packaging of solid dosage forms, specifically tablets and capsules, within the Packaging/Primary area.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Equipment Owner: Responsible for ensuring equipment is maintained and calibrated prior to OQ execution.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All necessary documentation and equipment manuals must be available.
- Personnel must be trained on the operation of the Blister Packing Machine.
Equipment Description
The Blister Packing Machine (Thermoform) is designed for the efficient packaging of tablets and capsules into blister packs. It operates by forming a plastic sheet into blisters, filling them with product, and sealing them with a lidding material.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify forming temperature | Within specified range as per URS Annex 11 | Temperature logs |
| OQ-02 | Verify sealing temperature | Within specified range as per URS Annex 11 | Temperature logs |
| OQ-03 | Verify dwell pressure | Within specified range as per URS Annex 11 | Pressure logs |
| OQ-04 | Verify reject PLC functionality | Rejects non-conforming products as per specifications | PLC logs |
Detailed Test Cases
OQ-01: Verify Forming Temperature
Procedure: Set the machine to the specified forming temperature and monitor for stability over a 30-minute period. Record the temperature at 5-minute intervals.
Acceptance Criteria: Temperature must remain within the limits defined in URS Annex 11.
Evidence: Temperature logs will be collected and reviewed.
OQ-02: Verify Sealing Temperature
Procedure: Set the machine to the specified sealing temperature and monitor for stability over a 30-minute period. Record the temperature at 5-minute intervals.
Acceptance Criteria: Temperature must remain within the limits defined in URS Annex 11.
Evidence: Temperature logs will be collected and reviewed.
OQ-03: Verify Dwell Pressure
Procedure: Set the machine to the specified dwell pressure and monitor pressure readings over a 30-minute period. Record pressure at 5-minute intervals.
Acceptance Criteria: Pressure must remain within the limits defined in URS Annex 11.
Evidence: Pressure logs will be collected and reviewed.
OQ-04: Verify Reject PLC Functionality
Procedure: Simulate a non-conforming product and verify that the PLC correctly identifies and rejects it. Document the results.
Acceptance Criteria: The PLC must reject all non-conforming products as specified.
Evidence: PLC logs will be collected and reviewed.
Deviations
Any deviations from the protocol must be documented and reviewed by the Quality Assurance team. A root cause analysis must be performed for any critical deviations.
Approvals
__________________________
Validation Team Lead
Date: ________________
__________________________
Quality Assurance Manager
Date: ________________