Document ID: IQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Prepared By]
Approved by: [Approved By]
Installation Qualification Protocol for Coding Machine (Inkjet / Laser)
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Coding Machine (Inkjet / Laser) is installed correctly and operates according to the specified requirements to ensure proper printing of batch and expiry details on packaging materials.
Scope
This protocol applies to the Installation Qualification of the Coding Machine (Inkjet / Laser) located in the packaging area for the production of suppositories and implants.
Responsibilities
Quality Assurance: Ensure compliance with validation protocols and regulatory requirements.
Engineering: Oversee installation and perform necessary checks.
Operations: Operate the equipment and report any discrepancies.
Prerequisites
1. Completed User Requirement Specification (URS) for the Coding Machine.
2. Installation of necessary utilities (power, water, air supply).
3. Training of personnel on equipment operation and safety protocols.
Equipment Description
The Coding Machine (Inkjet / Laser) is designed to print batch and expiry details on packaging materials for suppositories and implants. It ensures high print quality and includes an audit trail logging feature for compliance tracking.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to manufacturer specifications. | Installation matches the specifications in the URS Annex11. | Installation checklist signed by Engineering. |
| IQ-02 | Check utility connections (power, air, etc.). | All utilities are connected and functional. | Utility connection log. |
| IQ-03 | Perform print quality audit trail log check. | Audit logs are complete with no discrepancies. | Print quality audit log report. |
Detailed Test Cases
Test ID: IQ-01
Procedure: Verify installation according to manufacturer specifications.
Acceptance Criteria: Installation matches the specifications in the URS Annex11.
Evidence: Installation checklist signed by Engineering.
Test ID: IQ-02
Procedure: Check utility connections (power, air, etc.).
Acceptance Criteria: All utilities are connected and functional.
Evidence: Utility connection log.
Test ID: IQ-03
Procedure: Perform print quality audit trail log check.
Acceptance Criteria: Audit logs are complete with no discrepancies.
Evidence: Print quality audit log report.
Deviations
Any deviations from the procedures must be documented and reviewed by Quality Assurance for approval before proceeding with the validation process.
Approvals
Prepared by: ___________________ Date: ___________
Approved by: ___________________ Date: ___________
Data Integrity Checks
1. Ensure that all print quality logs are securely stored and backed up regularly.
2. Verify that access to the audit trail is restricted to authorized personnel only.
3. Conduct regular reviews of the audit logs to ensure compliance with regulatory standards.