Document Control
Document ID: OQ-TD-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Tablet Deduster
Objective: To validate the operational performance of the Tablet Deduster used in the production of solid dosage forms, ensuring it meets defined acceptance criteria and functions as intended.
Scope: This protocol applies to the Tablet Deduster located in the Production/Compression area, focusing on its use for dedusting tablets, which has a direct impact on product quality.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Personnel: Responsible for operating the Tablet Deduster during testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of necessary materials and equipment for testing.
- Training of personnel on the operation of the Tablet Deduster.
Equipment Description: The Tablet Deduster is an automated device designed to remove dust from compressed tablets to ensure product quality and compliance with specifications. It operates using vibration and airflow mechanisms to facilitate the dedusting process.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-TD-01 | Verify vibration settings | Vibration levels within specified range | Calibration report |
| OQ-TD-02 | Measure airflow rate | Airflow rate meets operational specifications | Airflow measurement log |
| OQ-TD-03 | Assess tablet damage | No visible damage to tablets post-dedusting | Photographic evidence |
Detailed Test Cases:
Test Case OQ-TD-01
Objective: To verify that the vibration settings of the Tablet Deduster are within the specified range.
Procedure: Operate the deduster and measure the vibration levels using a calibrated vibration meter.
Acceptance Criteria: Vibration levels must be within the range specified in the User Requirement Specification (URS).
Evidence: Document the readings and attach the calibration report.
Test Case OQ-TD-02
Objective: To measure the airflow rate of the Tablet Deduster.
Procedure: Use an anemometer to measure the airflow at the outlet of the deduster.
Acceptance Criteria: Airflow rate must meet the operational specifications outlined in the URS.
Evidence: Record the measurements in the airflow measurement log.
Test Case OQ-TD-03
Objective: To assess any potential damage to tablets post-dedusting.
Procedure: Inspect a sample of dedusted tablets for any visible damage.
Acceptance Criteria: No visible damage should be present on any of the tablets.
Evidence: Provide photographic evidence of the inspected tablets.
Deviations:
Any deviations from the acceptance criteria must be documented in a deviation report and reviewed by Quality Assurance. Actions taken to address deviations must be recorded and evaluated for impact on product quality.
Approvals:
All results must be reviewed and approved by the Validation Team and Quality Assurance before the Tablet Deduster can be deemed operationally qualified.