Standard Operating Procedure for Change Control

1) Purpose

The purpose of this SOP is to establish procedures for the initiation, review, approval, implementation, and closure of change controls to ensure controlled and systematic change management within the manufacturing facility.

2) Scope

This SOP applies to all changes impacting processes, equipment, facilities, materials, documentation, and systems within the facility that may affect product quality, safety, or efficacy.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Change Control Board (CCB):

Responsible for reviewing and approving change control requests.

3.2 Change Initiator:

Responsible for initiating change control requests and providing necessary documentation.

3.3 Quality Assurance (QA) Specialist:

Responsible for assessing change impact on product quality and regulatory compliance.

4) Procedure

4.1 Change Initiation:

4.1.1 Identify the need for change and complete the Change Control 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 change request for completeness and accuracy.
4.2.2 Assess impact of proposed change on processes, products, and regulatory compliance.
4.2.3 Assign priority and classification (e.g., major, minor) based on risk assessment.

4.3 Change Review and Approval:

4.3.1 Present change request to the Change Control Board (CCB) for review.
4.3.2 Obtain CCB approval based on