Procedure for Installation Qualification (IQ) of Equipment
| Department | Quality Assurance (QA)/Validation/Engineering/Production |
|---|---|
| SOP No. | SOP/Ointment/132 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting Installation Qualification (IQ) of new, modified, or relocated equipment in ointment manufacturing. This ensures that all installed equipment complies with predefined specifications and regulatory requirements.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for executing and documenting Installation Qualification (IQ) for equipment.
3. Responsibilities
- QA Officer: Ensures compliance with IQ protocols.
- Validation Team: Develops and executes IQ protocols.
- Engineering Team: Installs, calibrates, and verifies equipment functionality.
- Production Supervisor: Assists in verifying proper installation in manufacturing areas.
- QA Manager: Approves IQ reports and ensures proper documentation.
4. Accountability
The QA and Validation Managers are accountable for ensuring that Installation Qualification (IQ) is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Preparation for Installation Qualification (IQ)
- Ensure that the equipment is received in good condition with all necessary documentation, including:
- Manufacturer’s specifications
- Installation manuals
- Certificates of compliance
- Calibration certificates
- Verify that the installation site meets the environmental and utility requirements.
- Assign qualified personnel to conduct the IQ process.
5.2
Execution of Installation Qualification (IQ)
5.2.1 Verification of Equipment Components
- Check that all parts and accessories are as per the manufacturer’s list.
- Inspect the equipment for any physical damage or missing components.
- Verify that all required utilities (electrical, water, compressed air, etc.) are connected.
5.2.2 Equipment Installation Checks
- Confirm proper placement and alignment as per the installation drawings.
- Ensure secure and stable mounting of the equipment.
- Verify that all wiring and piping connections comply with safety standards.
5.2.3 Functional Testing
- Power on the equipment and check for normal startup operations.
- Ensure that all control panel functions and emergency stop buttons operate correctly.
- Perform initial calibration checks if applicable.
5.3 Documentation and Approval
- Record all installation verification details in the IQ Log.
- QA must review and approve the IQ results before moving to Operational Qualification (OQ).
- Maintain installation qualification records for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
7. Documents
- Installation Qualification Protocol (Annexure-1)
- Installation Qualification Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Equipment Qualification
- US FDA Guidance on Installation Qualification
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Installation Qualification Protocol
| Equipment Type | Verification Parameter | Acceptance Criteria |
|---|---|---|
| Mixing Tank | Electrical Connections | As per manufacturer specifications |
| Filling Machine | Alignment and Mounting | Properly secured and leveled |
Annexure-2: Installation Qualification Log
| Date | Equipment ID | Installation Check | Verification Status | Reviewed By |
|---|---|---|---|---|
| 01/02/2025 | MIX-1001 | Power Supply Verification | Pass | QA Manager |
| 02/02/2025 | FILL-2002 | Mechanical Stability | Pass | QA Manager |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |