Document Control
Protocol Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for Auto Coating Pan (Perforated Pan Coater)
Objective: To validate the operational performance of the Auto Coating Pan (Perforated Pan Coater) for film coating in solid dosage forms.
Scope: This protocol applies to the Auto Coating Pan used in the Production/Coating area for direct impact on product quality.
Responsibilities:
- Validation Team: Responsible for executing and documenting the OQ protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Staff: Responsible for operating the equipment during the qualification process.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of all necessary equipment and materials.
- Training of personnel on the operation of the Auto Coating Pan.
Equipment Description:
The Auto Coating Pan (Perforated Pan Coater) is designed for film coating of solid dosage forms. It operates with critical parameters including inlet/exhaust temperature, spray rate, pan speed, and PLC controls to ensure uniform coating application.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify inlet temperature during operation. | Inlet temp within specified range (URS Annex11) | Temperature log |
| OQ-02 | Verify exhaust temperature during operation. | Exhaust temp within specified range (URS Annex11) | Temperature log |
| OQ-03 | Verify spray rate during operation. | Spray rate within specified range (URS Annex11) | Flow rate log |
| OQ-04 | Verify pan speed during operation. | Pan speed within specified range (URS Annex11) | Speed log |
| OQ-05 | Verify PLC functionality and settings. | PLC settings match defined parameters (URS Annex11) | PLC configuration report |
Detailed Test Cases:
- Test ID: OQ-01
- Procedure: Monitor inlet temperature during operation.
- Acceptance Criteria: Inlet temperature must be within the specified range in URS Annex11.
- Evidence: Record and log temperature readings for validation.
- Test ID: OQ-02
- Procedure: Monitor exhaust temperature during operation.
- Acceptance Criteria: Exhaust temperature must be within the specified range in URS Annex11.
- Evidence: Record and log temperature readings for validation.
- Test ID: OQ-03
- Procedure: Measure the spray rate during operation.
- Acceptance Criteria: Spray rate must be within the specified range in URS Annex11.
- Evidence: Record flow rate data for validation.
- Test ID: OQ-04
- Procedure: Measure the pan speed during operation.
- Acceptance Criteria: Pan speed must be within the specified range in URS Annex11.
- Evidence: Record speed data for validation.
- Test ID: OQ-05
- Procedure: Verify PLC settings and functionality.
- Acceptance Criteria: PLC settings must match defined parameters in URS Annex11.
- Evidence: Document PLC configuration report.
Deviations: Any deviations from the acceptance criteria must be documented and investigated as per the deviation management procedure.
Approvals:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance Manager: ______________________ Date: __________
Data Integrity Checks:
- Ensure all data logs are timestamped and signed by the operator.
- Perform regular audits of data entries against raw data.
- Implement electronic data capture with access controls to prevent unauthorized changes.