Performance Qualification Protocol for Tablet Deduster
Document Number: PQ-TD-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Tablet Deduster operates within specified parameters and meets the requirements outlined in the User Requirement Specification (URS).
Scope
This protocol applies to the Tablet Deduster used in the Production/Compression area for the dedusting of tablets, with a direct impact on product quality.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Team: Responsible for providing access to the equipment and assisting with the execution of the protocol.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary tools and materials for testing.
- Training of personnel on the operation of the Tablet Deduster.
Equipment Description
The Tablet Deduster is designed to remove excess powder from tablets post-compression. It utilizes vibration and airflow to ensure that tablets are free from dust, thereby improving product quality and ensuring compliance with industry standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-01 | Measure vibration levels during operation. | Vibration levels must be within specified range as per URS. | Vibration Log |
| TP-02 | Assess airflow rates during operation. | Airflow must meet minimum requirements specified in URS. | Airflow Measurement Report |
| TP-03 | Inspect tablets for damage post-dedusting. | No visible damage on tablets. | Inspection Photographs |
Detailed Test Cases
Test Case TP-01: Vibration Level Measurement
Procedure: Use a calibrated vibration meter to measure the vibration levels of the Tablet Deduster during operation. Record the data.
Acceptance Criteria: Vibration levels must be within the specified range as outlined in the URS.
Test Case TP-02: Airflow Rate Assessment
Procedure: Utilize an airflow meter to measure the airflow rates during the operation of the Tablet Deduster. Document the readings.
Acceptance Criteria: Airflow must meet or exceed the minimum requirements specified in the URS.
Test Case TP-03: Tablet Damage Inspection
Procedure: After dedusting, visually inspect a sample of tablets for any signs of damage. Take photographs for documentation.
Acceptance Criteria: No visible damage should be present on the tablets.
Deviations
Any deviations from the protocol must be documented and justified. A root cause analysis should be performed for any critical failures.
Approvals
All results must be reviewed and approved by the Quality Assurance team before the protocol can be considered complete.