Document Control
Document Number: OQ-Capper-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Screw Capper in Solid Dosage Form
Meta Description: This document outlines the Operational Qualification (OQ) protocol for the Screw Capper used in Solid Dosage Form equipment validation, focusing on critical parameters and acceptance criteria.
Tags: Equipment Validation, Operational Qualification, Capper, Solid Dosage Form, Pharmaceutical
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Screw Capper operates within specified parameters and meets the acceptance criteria defined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Screw Capper used in the Packaging/Primary area for capping bottles, directly impacting 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.
- Maintenance Team: Responsible for ensuring the equipment is in proper working condition prior to OQ execution.
Prerequisites
- Equipment must be installed and operational.
- All relevant personnel must be trained on equipment operation.
- Calibration of equipment must be completed.
Equipment Description
The Screw Capper is designed for capping bottles in the packaging of solid dosage forms. It incorporates features such as torque range control, speed adjustment, reject sensors, and an audit trail for data integrity.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Verify torque range settings | Torque settings within specified range | Calibration report |
| OQ-02 | Test speed adjustment functionality | Speed settings respond accurately | Operational log |
| OQ-03 | Check reject sensors functionality | Reject sensors activate correctly | Test results |
| OQ-04 | Review audit trail | Audit trail logs all actions | Audit log report |
Detailed Test Cases
Test Case OQ-01: Verify Torque Range Settings
Procedure: Adjust the torque settings and measure the output. Compare against the defined torque range.
Acceptance: Torque settings must be within the specified range as per URS Annex 11.
Evidence: Documented results and calibration report.
Test Case OQ-02: Test Speed Adjustment Functionality
Procedure: Adjust the speed settings and observe the response. Ensure the equipment operates at the set speed.
Acceptance: Speed settings must respond accurately to adjustments.
Evidence: Operational log documenting speed adjustments.
Test Case OQ-03: Check Reject Sensors Functionality
Procedure: Simulate a reject scenario and verify that the reject sensors activate as expected.
Acceptance: Reject sensors must activate correctly and stop the capping process.
Evidence: Test results confirming sensor functionality.
Test Case OQ-04: Review Audit Trail
Procedure: Access the audit trail and review logs for completeness and accuracy.
Acceptance: Audit trail must log all actions taken during operation.
Evidence: Audit log report showing logged actions.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan must be developed and approved by Quality Assurance.
Approvals
Prepared By: ____________________ Date: ___________
Approved By: ____________________ Date: ___________