Operational Qualification Protocol for Inline Sifter in Solid Dosage Form
Document Number: OQ-IS-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 Inline Sifter operates within established parameters and meets the requirements specified in the User Requirement Specification (URS).
Scope
This protocol applies to the Inline Sifter used in the Production/Sieving area for the sifting process during the transfer of solid dosage forms. It covers the critical parameters that directly impact product quality.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ documentation.
- Production Team: Responsible for providing access to the equipment and supporting the validation effort.
Prerequisites
- Completion of Installation Qualification (IQ) for the Inline Sifter.
- Availability of the Inline Sifter in the production area.
- Training of personnel on the equipment operation.
Equipment Description
The Inline Sifter is designed for sifting powder materials during transfer. It ensures that the product meets quality standards by removing oversized particles and contaminants. The key critical parameters for this equipment include:
- Flow Rate
- Screen Differential Pressure (DP)
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-1 | Measure flow rate during operation. | Flow rate within specified limits as per URS. | Flow rate log sheet. |
| OQ-2 | Monitor screen DP during operation. | Screen DP within specified limits as per URS. | Screen DP log sheet. |
Detailed Test Cases
Test Case OQ-1: Flow Rate Measurement
Objective: To verify that the flow rate of the material through the Inline Sifter meets the specified criteria.
Procedure: Operate the Inline Sifter under normal conditions and record the flow rate.
Acceptance Criteria: Flow rate must be within the limits defined in the URS.
Expected Outcome: Flow rate readings fall within acceptable limits.
Test Case OQ-2: Screen Differential Pressure Monitoring
Objective: To ensure that the screen differential pressure remains within acceptable limits during operation.
Procedure: Monitor the screen differential pressure while the Inline Sifter is in operation.
Acceptance Criteria: Screen DP must be within the limits defined in the URS.
Expected Outcome: Screen DP readings fall within acceptable limits.
Deviations
Any deviations from the acceptance criteria must be documented, along with an investigation and corrective actions taken. All deviations require approval from Quality Assurance before proceeding.
Approvals
Prepared by: [Name, Title, Date]
Reviewed by: [Name, Title, Date]
Approved by: [Name, Title, Date]