Installation Qualification Protocol for Tablet and Capsule Counter Filler
Document Number: IQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Tablet/Capsule Counter Filler is installed according to manufacturer specifications and is functioning as intended prior to operational qualification.
Scope
This protocol applies to the installation and qualification of the Tablet/Capsule Counter Filler located in the Packaging/Primary area. It covers all critical aspects that impact the product directly.
Responsibilities
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Maintenance Team: Responsible for ensuring the equipment is installed correctly and maintained.
Prerequisites
- Installation Manual of the Tablet/Capsule Counter Filler.
- Site Preparation Checklist.
- Calibration Certificates for all associated instruments.
Equipment Description
The Tablet/Capsule Counter Filler is designed to count and fill tablets and capsules into bottles. The equipment features advanced counting technology to ensure accuracy and efficiency in the packaging process.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to the manufacturer’s specifications. | All components installed as per the manual. | Installation checklist signed off. |
| IQ-02 | Check counting accuracy. | Counting accuracy within ±1% of the actual count. | Counting accuracy report. |
| IQ-03 | Validate speed of operation. | Speed meets specified requirements in URS Annex11. | Operational speed test results. |
| IQ-04 | Check reject functionality. | Reject mechanism activates for out-of-spec counts. | Reject test report. |
| IQ-05 | Audit trail functionality check. | Audit trail is complete and accessible. | Audit trail log report. |
Detailed Test Cases
Test Case: IQ-01
Procedure: Verify installation according to the manufacturer’s specifications.
Acceptance Criteria: All components installed as per the manual.
Evidence: Installation checklist signed off.
Test Case: IQ-02
Procedure: Check counting accuracy.
Acceptance Criteria: Counting accuracy within ±1% of the actual count.
Evidence: Counting accuracy report.
Test Case: IQ-03
Procedure: Validate speed of operation.
Acceptance Criteria: Speed meets specified requirements in URS Annex11.
Evidence: Operational speed test results.
Test Case: IQ-04
Procedure: Check reject functionality.
Acceptance Criteria: Reject mechanism activates for out-of-spec counts.
Evidence: Reject test report.
Test Case: IQ-05
Procedure: Audit trail functionality check.
Acceptance Criteria: Audit trail is complete and accessible.
Evidence: Audit trail log report.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the Validation Team and Quality Assurance for further action.
Approvals
Prepared By: [Insert Name]
Approved By: [Insert Name]