Document Control Number: OQ-001
Revision Number: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Tablet Compression Machine (Double Rotary)
Objective
The objective of this Operational Qualification (OQ) is to verify that the Tablet Compression Machine (Double Rotary) operates according to its intended use and meets the specified acceptance criteria.
Scope
This protocol applies to the Tablet Compression Machine (Double Rotary) located in the Production/Compression area, intended for high output tablet compression with direct product impact.
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 providing assistance and access to the equipment.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of necessary tools and documentation.
- Training of personnel on the equipment operation.
Equipment Description
The Tablet Compression Machine (Double Rotary) is designed for high output production of tablets. It features dual rotary compression, allowing for efficient and uniform tablet formation. Key parameters include speed, force, weight control, and reject functionality.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify operational parameters at specified settings. | Parameters within URS Annex11 specifications. | Calibration records, operator logs. |
| OQ-02 | Test speed control functionality. | Speed within ±5% of target. | Speed test results. |
| OQ-03 | Test force application consistency. | Force variation ≤ 2% across samples. | Force measurement data. |
| OQ-04 | Check weight control accuracy. | Weight deviation ≤ 3% from target weight. | Weight test results. |
| OQ-05 | Evaluate reject functionality. | Reject mechanism operational with <5% reject rate. | Reject log data. |
Detailed Test Cases
Test Case OQ-01
Procedure: Operate the machine at specified settings for a duration of 30 minutes. Record all operational parameters.
Acceptance Criteria: All parameters must be within the limits defined in URS Annex11.
Evidence: Calibration records, operator logs.
Test Case OQ-02
Procedure: Adjust the speed control to the maximum setting and record the speed.
Acceptance Criteria: Speed must be within ±5% of the target.
Evidence: Speed test results.
Test Case OQ-03
Procedure: Measure the force applied during tablet compression.
Acceptance Criteria: Force variation must be ≤ 2% across samples.
Evidence: Force measurement data.
Test Case OQ-04
Procedure: Weigh tablets produced and compare with target weight.
Acceptance Criteria: Weight deviation must be ≤ 3% from target weight.
Evidence: Weight test results.
Test Case OQ-05
Procedure: Activate the reject functionality and assess its performance.
Acceptance Criteria: Reject mechanism must operate effectively with a reject rate of <5%.
Evidence: Reject log data.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality and compliance. An investigation report must be generated for significant deviations.
Approvals
Prepared By: [Insert Name]
Approved By: [Insert Name]
Validation Manager: [Insert Name]