Operational Qualification (OQ) Protocol for Tablet/Capsule Counter Filler
Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Tablet/Capsule Counter Filler operates according to the specifications outlined in the User Requirement Specification (URS) Annex 11, ensuring accurate counting and filling of tablets and capsules into bottles.
Scope
This protocol applies to the Operational Qualification of the Tablet/Capsule Counter Filler used in the Packaging/Primary area for solid dosage forms. It addresses the critical parameters, including counting accuracy, speed, rejects, and audit trail functionality.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Equipment Owner: Responsible for ensuring the equipment is properly maintained and available for qualification.
Prerequisites
- Equipment must be installed and operational.
- All personnel involved in the qualification must be trained on the equipment and procedures.
- Calibration certificates for the equipment must be available.
Equipment Description
The Tablet/Capsule Counter Filler is designed to accurately count and fill tablets and capsules into bottles. The equipment features a counting mechanism that ensures high-speed operation with minimal rejects. The system maintains an audit trail for all operations performed.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify counting accuracy using a calibrated weight. | Counting accuracy within ±1% of target count. | Calibration report and test results. |
| OQ-02 | Measure filling speed with a stopwatch. | Filling speed meets or exceeds 100 bottles per hour. | Time logs and test results. |
| OQ-03 | Test reject functionality with defective tablets. | Reject rate ≤ 2% of total count. | Test results and reject logs. |
| OQ-04 | Verify audit trail functionality by logging operations. | All operations logged with timestamps. | Audit trail report. |
Detailed Test Cases
Test Case OQ-01: Verify Counting Accuracy
Procedure: Use a calibrated weight to count a predetermined number of tablets. Compare the counted number with the actual number.
Acceptance Criteria: Counting accuracy within ±1% of target count.
Evidence: Calibration report and test results.
Test Case OQ-02: Measure Filling Speed
Procedure: Fill bottles with tablets while timing the operation.
Acceptance Criteria: Filling speed meets or exceeds 100 bottles per hour.
Evidence: Time logs and test results.
Test Case OQ-03: Test Reject Functionality
Procedure: Introduce defective tablets and observe the reject mechanism.
Acceptance Criteria: Reject rate ≤ 2% of total count.
Evidence: Test results and reject logs.
Test Case OQ-04: Verify Audit Trail Functionality
Procedure: Perform a series of operations and review the audit trail logs.
Acceptance Criteria: All operations logged with timestamps.
Evidence: Audit trail report.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed. A detailed investigation will be conducted to determine the cause and necessary corrective actions.
Approvals
Validation Team Lead: ______________________ Date: _______________
Quality Assurance: ______________________ Date: _______________
Equipment Owner: ______________________ Date: _______________
Data Integrity Checks
As CSV is required, data integrity checks will include:
- Validation of data entry processes to ensure accurate recording of counts.
- Regular audits of electronic records to confirm compliance with data integrity standards.
- Backup procedures to prevent data loss.