require changes to the equipment or process, and ensuring that the equipment operates according to specifications after changes are made.

Quality Assurance (QA) Team: Responsible for reviewing and approving all changes and ensuring that the equipment revalidation process is followed to maintain compliance with GMP standards and regulatory requirements.

Change Control Board (CCB): Responsible for evaluating and approving changes that affect equipment performance, ensuring that the changes do not compromise product quality or compliance.

4. Accountability

The Manufacturing Manager is accountable for ensuring that any changes to equipment during validation are managed according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identifying Changes

1. Any changes to equipment, its components, or its operation should be identified by the Engineering, Maintenance, or Production teams. These changes may include, but are not limited to:
   • Modification or replacement of equipment parts
   • Changes in machine settings or operating parameters
   • Installation of new software or control systems
   • Upgrades to equipment to meet regulatory requirements or improve performance
2. All changes should be documented in the Change Control Log (Annexure-1) and submitted for evaluation.

5.2. Evaluating Changes

1. Upon identification of a change, the Change Control Board (CCB) should be convened to evaluate the impact of the change on equipment performance and product quality. The CCB will consider the following:
   • Whether the change will affect equipment performance, operational parameters, or quality control
   • Whether the change impacts previously conducted validation activities (e.g., Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ))
   • Whether revalidation or additional testing is required
   • The regulatory and compliance implications of the change
2. Document the evaluation results, including the reason for the change and any required actions (e.g., revalidation, retesting, adjustments).

5.3. Implementing Changes

1. Once a change is approved by the CCB, the necessary modifications should be made to the equipment or process as per the approved change plan.
2. The Engineering and Maintenance teams are responsible for implementing the changes according to the approved specifications. During implementation, all activities should be documented to ensure traceability and accountability.
3. If revalidation or additional testing is required, it should be planned and executed as outlined in the original validation protocol or any updated testing protocols.

5.4. Documenting the Change Control Process

1. All changes must be documented in the Change Control Log (Annexure-1) and should include the following details:
   • Change ID
   • Description of the change
   • Reason for the change
   • Impact on equipment performance, compliance, or product quality
   • Testing or validation required post-change
   • Implementation details
   • Approvals from the Change Control Board and other relevant stakeholders
2. Ensure that the documentation is clear, complete, and accessible for future reference or audits.

5.5. Revalidating the Equipment After Changes

1. If the change affects the equipment’s performance, compliance, or product quality, revalidation will be required. This may include:
   • Reinstalling equipment and performing Installation Qualification (IQ)
   • Conducting Operational Qualification (OQ) to ensure the equipment operates as expected
   • Completing Performance Qualification (PQ) to verify the equipment produces the desired product quality
2. Ensure that all validation tests are documented in the Equipment Revalidation Report (Annexure-2), and any deviations or corrective actions are recorded in the Deviation Log (Annexure-3).
3. The QA team should review and approve the revalidation results, ensuring that all tests are successful and the equipment is compliant with regulatory requirements.

5.6. Closing the Change Control Process

1. Once all changes have been implemented and any required revalidation is complete, the Change Control process can be closed.
2. The Change Control Log should be updated to reflect that the change has been completed and all necessary testing, documentation, and approvals are in place.
3. Ensure that the final documentation is archived for future audits and inspections.

6. Abbreviations

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

7. Documents

1. Change Control Log (Annexure-1)
2. Equipment Revalidation Report (Annexure-2)
3. Deviation Log (Annexure-3)

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: Change Control Log

Change ID	Change Description	Reason for Change	Impact	Approval Status	Implementation Date
CC-001	Installed new sensor in filling machine	Improved measurement accuracy	No impact on performance	Approved	06/02/2025

Annexure-2: Equipment Revalidation Report

Equipment ID	Model Number	Serial Number	Test Date	Test Type	Result
FILL-001	Model A	SN123456	06/02/2025	Revalidation Test	Pass

Annexure-3: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Sensor malfunctioned	Replaced sensor	Rajesh Patel	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 change control procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures