Standard Operating Procedure for Change Management

1) Purpose

The purpose of this SOP is to establish procedures for the management of changes to facilities, equipment, materials, processes, and documentation to ensure controlled and effective change management within the manufacturing facility.

2) Scope

This SOP applies to all departments and functions within the manufacturing facility that are responsible for initiating, evaluating, implementing, and verifying changes.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Change Control Board (CCB):

Responsible for reviewing and approving changes based on impact assessment and risk evaluation.

3.2 Change Initiator:

Responsible for initiating change requests and providing necessary documentation and justification.

3.3 Quality Assurance (QA) Specialist:

Responsible for assessing change impact on product quality and regulatory compliance and ensuring change control processes are followed.

4) Procedure

4.1 Change Request Initiation:

4.1.1 Identify the need for change and complete the Change Request Form.
4.1.2 Include details such as reason for change, scope, and potential impact.
4.1.3 Obtain approval from the Change Initiator’s supervisor.

4.2 Change Evaluation:

4.2.1 Review the Change Request Form for completeness and accuracy.
4.2.2 Assess the impact of the proposed change on product quality, safety, efficacy, and regulatory compliance.
4.2.3 Conduct risk assessment to determine the level of change control required.

4.3 Change Approval:

4.3.1 Present the change request and evaluation findings to the Change Control Board (CCB).
4.3.2 Obtain approval or rejection of the change request based on CCB decision.
4.3.3 Document CCB approval and communicate decisions to relevant stakeholders.

4.4 Change Implementation:

4.4.1 Develop an implementation plan including timelines, responsibilities, and resources.
4.4.2 Execute the change in accordance with approved procedures and protocols.
4.4.3 Verify and validate the effectiveness of the change through testing and validation activities.

4.5 Change Verification and Closure:

4.5.1 Verify completion of change implementation and compliance with approved procedures.
4.5.2 Close the Change Request Form and update relevant documentation and records.
4.5.3 Review and document lessons learned from the change management process.

5) Abbreviations, if any

CCB – Change Control Board
QA – Quality Assurance

6) Documents, if any

1. Change Request Form
2. Change Evaluation Report
3. Implementation Plan
4. Verification and Validation Reports

7) Reference, if any

1. FDA Guidance for Industry: Change Control – Implementation and Management Systems for Pharmaceutical and Biotechnology Manufacturing
2. ISO 13485 Medical devices – Quality management systems

8) SOP Version

Version 1.0