Document Control:
Protocol Number: IQ-OSD-IS-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Inline Sifter in Solid Dosage Form Production
Objective: To verify that the Inline Sifter is installed according to the manufacturer’s specifications and is suitable for use in the production of solid dosage forms.
Scope: This protocol applies to the Installation Qualification of the Inline Sifter used in the sieving process during the transfer of solid dosage forms in the production area.
Responsibilities:
- Validation Team: Prepare and execute the Installation Qualification protocol.
- Production Team: Provide necessary access and support during the qualification process.
- Quality Assurance: Review and approve the protocol and results.
Prerequisites:
- Completion of equipment installation.
- Training of personnel on equipment operation.
- Availability of necessary documentation (URS, manufacturer specifications).
Equipment Description: The Inline Sifter is designed to ensure the uniformity and quality of solid dosage forms by sifting materials during transfer. It operates under controlled flow rates and utilizes a screen to separate particles based on size.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation against manufacturer’s specifications. | All components installed as per specifications. | Installation checklist signed off. |
| IQ-02 | Check flow rate and differential pressure (DP) settings. | Flow rate within defined limits; DP meets specifications. | Calibration records and flow rate measurements. |
Detailed Test Cases:
- Test Case IQ-01: Confirm that the Inline Sifter is installed in the designated area with all components properly secured and aligned.
- Test Case IQ-02: Measure the flow rate at various settings to ensure it meets the acceptance criteria defined in the URS. Record differential pressure readings to confirm they are within specified limits.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on equipment performance and product quality. A deviation report shall be submitted for review and approval.
Approvals:
- Prepared By: ________________________ Date: ___________
- Reviewed By: ________________________ Date: ___________
- Approved By: ________________________ Date: ___________