Standard Operating Procedure for Change Control Management

1) Purpose

This SOP outlines the procedures for initiating, evaluating, implementing, and documenting changes to processes, systems, facilities, equipment, and documents to ensure controlled and systematic change management while maintaining compliance with regulatory requirements.

2) Scope

This SOP applies to all departments and personnel involved in initiating, assessing, approving, implementing, and verifying changes within the company, including manufacturing, quality assurance, engineering, and regulatory affairs.

3) Responsibilities

The Change Control Board (CCB) is responsible for overseeing the change control process. The Quality Assurance (QA) department coordinates and facilitates change control activities, and all relevant departments are responsible for initiating and supporting change requests.

4) Procedure

4.1 Change Request Initiation

1. Any department or personnel identifying the need for a change must initiate a Change Request (CR) using the Change Request Form.
2. Complete the CR Form with details such as the reason for the change, description of the change, proposed implementation plan, and potential impact assessment.
3. Submit the CR Form to the QA department for initial review and assignment of a CR number.

4.2 Change Evaluation and Impact Assessment

1. The QA department assesses the CR to determine its impact on product quality, safety, efficacy, regulatory compliance, and other relevant factors.
2. Assign a cross-functional Change Control Team (CCT) to conduct a detailed impact assessment, considering technical, regulatory, financial, and operational aspects.
3. Document the evaluation findings and recommendations in the CR Evaluation Report Form.

4.3 Change Review and Approval

1. Review the CR and CR Evaluation Report Form at a scheduled CCB meeting.
2. Evaluate the proposed change against predefined criteria, including risk assessment, regulatory requirements, and business impact.
3. Approve or reject the change request based on the CCB’s evaluation and recommendation.

4.4 Change Implementation

1. Develop a detailed Change Implementation Plan (CIP) for approved changes, including specific tasks, timelines, responsible parties, and validation requirements.
2. Execute the CIP according to the approved plan, ensuring all activities are documented and verified.
3. Coordinate with relevant departments to communicate and train personnel on the implemented changes.

4.5 Change Verification and Validation

1. Verify the effectiveness of implemented changes through validation, testing, or other verification activities as required.
2. Document the results of verification and validation activities in the Change Verification Report Form.
3. Obtain final approval from the QA department or designated approver before closing the change request.

4.6 Change Closure and Documentation

1. Review all documentation related to the change request, including CR Form, CR Evaluation Report Form, CIP, and Change Verification Report Form.
2. Close the change request in the change control system and archive all relevant documents.
3. Ensure that all documentation is complete, accurate, and accessible for audits and regulatory inspections.

5) Abbreviations, if any

QA: Quality Assurance
CCB: Change Control Board
CCT: Change Control Team
SOP: Standard Operating Procedure
CR: Change Request
CIP: Change Implementation Plan

6) Documents, if any

Change Request Form, CR Evaluation Report Form, Change Implementation Plan, Change Verification Report Form

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q10 (Pharmaceutical Quality System), and ISO 13485 (Medical Devices – Quality Management Systems)

8) SOP Version

Version 1.0