Installation Qualification Protocol for the Auto Coating Pan
Document Number: IQ-ACP-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Reviewed by: [Insert Name]
Approved by: [Insert Name]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Auto Coating Pan (Perforated Pan Coater) is installed according to the manufacturer’s specifications and is suitable for its intended use in film coating of solid dosage forms.
Scope
This protocol applies to the Auto Coating Pan located in the Production/Coating area. It covers the installation and operational verification of the equipment as it pertains to film coating processes.
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 and maintained according to specifications.
Prerequisites
- Completion of equipment installation by the vendor.
- Availability of the manufacturer’s installation manual.
- Completion of necessary safety training for personnel involved in the IQ execution.
Equipment Description
The Auto Coating Pan (Perforated Pan Coater) is designed for the film coating of solid dosage forms. It operates by spraying a coating solution onto the tablets while they are tumbled in a perforated pan. Key critical parameters include inlet/exhaust temperature, spray rate, pan speed, and PLC settings.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation of the Auto Coating Pan according to the manufacturer’s specifications. | All components installed as per specifications. | Installation checklist signed by the vendor. |
| IQ-02 | Check critical parameters: Inlet/exhaust temperature, spray rate, pan speed, PLC. | Parameters within specified limits as per URS Annex11. | Calibration certificates and parameter logs. |
| IQ-03 | Conduct data integrity checks for CSV compliance. | All data entries are complete and accurate. | Data integrity check report. |
Detailed Test Cases
Test Case: IQ-01
Procedure: Verify installation of the Auto Coating Pan according to the manufacturer’s specifications.
Acceptance Criteria: All components installed as per specifications.
Evidence: Installation checklist signed by the vendor.
Test Case: IQ-02
Procedure: Check critical parameters: Inlet/exhaust temperature, spray rate, pan speed, PLC.
Acceptance Criteria: Parameters within specified limits as per URS Annex11.
Evidence: Calibration certificates and parameter logs.
Test Case: IQ-03
Procedure: Conduct data integrity checks for CSV compliance.
Acceptance Criteria: All data entries are complete and accurate.
Evidence: Data integrity check report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A deviation report shall be completed and reviewed by the Quality Assurance department.
Approvals
This protocol must be approved by the following personnel:
- Prepared by: ____________________
- Reviewed by: ____________________
- Approved by: ____________________