Performance Qualification Protocol for Double Rotary Tablet Compression Machine
Document Control
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Tablet Compression Machine (Double Rotary) operates consistently and reliably within specified limits to ensure the quality of the tablet product.
Scope
This protocol applies to the Tablet Compression Machine used in the production of solid dosage forms (OSD) within the Production/Compression area. It is intended for all personnel involved in equipment validation and qualification.
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 Personnel: Responsible for operating the equipment as per the protocol.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the use of the Tablet Compression Machine.
- Availability of necessary materials and equipment for testing.
Equipment Description
The Tablet Compression Machine (Double Rotary) is designed for high output tablet compression. It utilizes dual rotary motion to compress powder into tablets efficiently. Key features include adjustable speed, force control, and weight control mechanisms.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Verify speed settings at various levels. | Speed within specified range as per URS Annex11. | Calibration report, logbook entry. |
| TP-002 | Measure force applied during compression. | Force within specified limits as per URS Annex11. | Force measurement report, logbook entry. |
| TP-003 | Check weight control accuracy. | Weight variation within acceptable limits as per URS Annex11. | Weight verification report, logbook entry. |
| TP-004 | Evaluate reject rate during production. | Reject rate below specified threshold as per URS Annex11. | Production report, logbook entry. |
Detailed Test Cases
Test Case: Speed Verification
Procedure: Adjust the speed settings on the machine and record the actual speed. Compare with the target speed.
Acceptance Criteria: Speed must be within ±5% of the target speed.
Evidence: Calibration report and logbook entries to be maintained for verification.
Test Case: Force Measurement
Procedure: Measure the force applied during compression using a calibrated force gauge.
Acceptance Criteria: Force must be within ±10% of the specified limits.
Evidence: Force measurement report and logbook entries.
Test Case: Weight Control Assessment
Procedure: Weigh a sample of tablets produced and calculate the average weight.
Acceptance Criteria: Average weight must be within ±5% of the target weight.
Evidence: Weight verification report and logbook entries.
Test Case: Reject Rate Evaluation
Procedure: Monitor the reject rate during a production run and document the number of rejects.
Acceptance Criteria: Reject rate must be less than 2%.
Evidence: Production report and logbook entries.
Deviations
Any deviations from the acceptance criteria must be documented, investigated, and approved by Quality Assurance before proceeding with production.
Approvals
Approved By: [Insert Name], Quality Assurance
Date: [Insert Date]
Approved By: [Insert Name], Validation Team Lead
Date: [Insert Date]