Operational Qualification Protocol for Roller Compactor in Dry Granulation
Document Number: OQ-RC-001
Version: 1.0
Date: 2023-10-04
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Roller Compactor operates according to its intended use and meets the specified acceptance criteria outlined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Roller Compactor used in the Production/Dry Granulation area for the manufacture of solid dosage forms.
Responsibilities
The Validation Team is responsible for executing the protocol, documenting results, and ensuring compliance with regulatory requirements.
Prerequisites
All staff involved in the execution of this protocol must be trained in the operation of the Roller Compactor and have completed relevant GMP training.
Equipment Description
The Roller Compactor is designed for dry granulation of powders. It utilizes roll pressure, gap, speed, and feed rate to achieve desired granule characteristics. The PLC controls these parameters for precise operation.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-RC-001-01 | Verify roll pressure settings. | Within specified range as per URS. | Calibration logs. |
| OQ-RC-001-02 | Check gap settings. | Within specified range as per URS. | Measurement logs. |
| OQ-RC-001-03 | Validate speed settings. | Within specified range as per URS. | Operational logs. |
| OQ-RC-001-04 | Assess feed rate accuracy. | Within specified range as per URS. | Feed rate logs. |
| OQ-RC-001-05 | PLC functionality check. | All functions operate as intended. | PLC test results. |
Detailed Test Cases
Test Case 1: Verify Roll Pressure Settings
Procedure: Set roll pressure to specified values and record.
Acceptance: Roll pressure must be within the range defined in URS.
Evidence: Calibration logs must be attached.
Test Case 2: Check Gap Settings
Procedure: Adjust gap settings and measure.
Acceptance: Gap must be within the specified range in URS.
Evidence: Measurement logs must be attached.
Test Case 3: Validate Speed Settings
Procedure: Set speed to specified values and record.
Acceptance: Speed must be within the range defined in URS.
Evidence: Operational logs must be attached.
Test Case 4: Assess Feed Rate Accuracy
Procedure: Measure feed rate during operation.
Acceptance: Feed rate must be within specified range in URS.
Evidence: Feed rate logs must be attached.
Test Case 5: PLC Functionality Check
Procedure: Test all PLC functions.
Acceptance: All functions operate as intended.
Evidence: PLC test results must be attached.
Deviations
Any deviations from the protocol must be documented and approved by the Validation Manager.
Approvals
Prepared by: ___________________ Date: __________
Approved by: ___________________ Date: __________