Operational Qualification Protocol for Flake Crusher in Production/Dry Granulation
Document ID: OQ-FC-001
Version: 1.0
Effective Date: [Insert Date]
Review 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 Flake Crusher operates according to the specified acceptance criteria and to ensure that it meets the requirements outlined in the User Requirement Specification (URS).
Scope
This protocol applies to the Flake Crusher used in the Production/Dry Granulation area for the crushing of ribbons/flakes in the manufacturing of solid dosage forms. It encompasses all relevant operational parameters and acceptance criteria.
Responsibilities
- Validation Team: Responsible for executing and documenting the OQ protocol.
- Production Team: Ensure the availability of the equipment and provide necessary support during testing.
- Quality Assurance: Review and approve the OQ protocol and results.
Prerequisites
- Completion of Installation Qualification (IQ) for the Flake Crusher.
- Availability of necessary documentation including User Requirement Specification (URS).
- Training of personnel on the operation of the Flake Crusher.
Equipment Description
The Flake Crusher is designed to crush ribbons and flakes produced from the roller compaction process. It operates by utilizing a high-speed mechanism to achieve the desired particle size distribution (PSD). The equipment is critical in ensuring uniformity and quality of the final product.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Measure speed of the Flake Crusher during operation. | Speed within specified range as per URS. | Calibration records and operational logs. |
| OQ-02 | Evaluate screen output particle size distribution (PSD). | PSD meets acceptance criteria as per URS. | Particle size analysis report. |
Detailed Test Cases
Test Case OQ-01
Objective: To verify the operational speed of the Flake Crusher.
Procedure: Operate the Flake Crusher and record the speed using a calibrated tachometer. Compare the recorded speed with the specified range in the URS.
Acceptance Criteria: Speed must be within the specified range.
Evidence: Documented speed readings and calibration certificate.
Test Case OQ-02
Objective: To assess the particle size distribution (PSD) of the crushed material.
Procedure: Collect samples of the crushed product and analyze using a laser diffraction particle size analyzer. Compare the results with the acceptance criteria in the URS.
Acceptance Criteria: PSD must meet the specified limits.
Evidence: Particle size analysis report and raw data.
Deviations
Any deviations from the specified procedures or acceptance criteria must be documented and justified. A deviation report must be submitted for review and approval by Quality Assurance.
Approvals
Prepared by: ________________________ Date: ____________
Approved by: ________________________ Date: ____________