complies with GMP standards and regulatory requirements.

Maintenance Team: Responsible for ensuring that all installation-related maintenance tasks are completed and documented appropriately.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the Installation Qualification process is conducted as part of the equipment commissioning process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Installation Qualification

1. Before starting the IQ process, ensure that the equipment is physically installed in the appropriate location as per the manufacturer’s guidelines and the equipment layout plan.
2. Ensure that all necessary documents are available, including the equipment manual, technical specifications, and installation instructions from the manufacturer.
3. Verify that all utilities (e.g., electricity, compressed air, water supply) required for the operation of the equipment are available and connected properly.
4. Establish the Installation Qualification team, which should include representatives from the Engineering, Production, and QA teams.
5. Ensure that any necessary calibration tools, testing devices, and measurement instruments are available for use during the IQ process.

5.2. Conducting the Installation Qualification

1. Verify that the equipment is installed according to the manufacturer’s specifications, including:
   • Correct placement and alignment of all components
   • Secure attachment of all parts
   • Correct connections for power, utilities, and communication interfaces
2. Ensure that all safety features are installed and operational, including emergency stop buttons, safety guards, and interlocks.
3. Verify that all equipment components are labeled properly according to the manufacturer’s instructions.
4. Perform a visual inspection of the equipment to ensure that it is free from physical damage, defects, or missing parts.
5. Ensure that any installation-specific testing (e.g., system functionality tests) is performed, as described in the equipment manual or manufacturer’s guidelines.

5.3. Documenting the Installation Qualification

1. Document the following information in the Installation Qualification Report (Annexure-1):
   • Details of the equipment being qualified (e.g., equipment ID, model, serial number)
   • Location and date of installation
   • Verification of installation steps, including any deviations or non-compliance
   • Results of all tests performed (e.g., functional tests, safety checks)
   • Signatures of the personnel involved in the IQ process
2. Ensure that the IQ report is signed by the Engineering team, the Production team, and the QA team.
3. The completed Installation Qualification Report should be stored as part of the equipment qualification documentation.

5.4. Reviewing and Approving the Installation Qualification

1. The Installation Qualification Report should be reviewed and approved by the QA team to ensure that the equipment meets the specified installation requirements and is ready for the next qualification phase (Operational Qualification or Performance Qualification).
2. If any deviations or non-conformities are identified during the IQ process, they should be documented in the Deviation Log (Annexure-2) and appropriate corrective actions should be taken.
3. The QA team should approve the report once all required steps are complete and any deviations are addressed.

5.5. Finalizing the IQ Process

1. Once the Installation Qualification is complete and approved, the equipment can proceed to the next phase of qualification (Operational Qualification or Performance Qualification).
2. Ensure that all documentation, including the Installation Qualification Report and any supporting documents (e.g., deviation reports, corrective actions), are archived and accessible for future audits and reviews.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• IQ: Installation Qualification

7. Documents

1. Installation Qualification Report (Annexure-1)
2. Deviation Log (Annexure-2)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• International Council for Harmonisation (ICH) Guidelines

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 Report

Equipment ID	Model Number	Serial Number	Installation Date	Location	Inspection Results
FILL-001	Model A	SN123456	06/02/2025	Production Line 1	Pass
FILL-002	Model B	SN789012	06/02/2025	Production Line 2	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Equipment alignment issue	Re-aligned components	Rajesh Patel	Completed
DEV-12346	Power supply issue	Replaced power cable	Vikas Sharma	Completed

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated installation verification procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures