SOP for Operational Qualification of Dissolution Tester.
Standard Operating Procedure(SOP)
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1. Purpose
To define the procedure for performing Operational Qualification (OQ) of the dissolution tester to ensure it operates according to predetermined specifications.
2. Scope
Applicable to all dissolution testers installed in the Quality Control (QC) or R&D laboratories.\
3. Responsibility
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QA Department: To review and approve the OQ report.
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Engineering/Validation Team: To execute the qualification protocol.
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QC Analyst: To assist and document observations during qualification.
4. References
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Equipment Manufacturer’s Manual
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ICH Q8/Q9/Q10 Guidelines
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USP <711> Dissolution
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WHO/USFDA/EMA guidelines as applicable
5. Equipment & Materials Required
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Calibrated thermometer, tachometer, stopwatch
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Dissolution vessels and paddles/baskets
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Standard calibration tablets (if applicable)
6. Procedure
6.1 General Inspection
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Check physical condition of the equipment.
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Verify cleanliness and proper installation.
6.2 Functional Verification
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Test RPM (e.g., verify 50, 75, 100 RPM settings).
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Temperature accuracy (usually at 37 ± 0.5°C).
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Timer function validation.
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Basket/paddle centering and height adjustment checks.
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Vibration and noise level observation.
6.3 System Suitability Test
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Perform a trial run with standard tablets.
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Measure and document consistency across vessels.
7. Acceptance Criteria
All functional parameters should fall within the manufacturer’s and regulatory specified limits.
8. Documentation
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Record all observations, deviations, and corrective actions.
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OQ report to be reviewed and approved by QA.
9. Change Control
Any changes to equipment or procedures must go through the approved change control process.
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