Standard Operating Procedure for Change Control
1) Purpose
The purpose of this SOP is to establish procedures for the control, documentation, and implementation of changes to facilities, systems, equipment, processes, and documents to ensure product quality, safety, and efficacy.
2) Scope
This SOP applies to all changes within the manufacturing facility that may impact product quality, safety, efficacy, or regulatory compliance.
3) Responsibilities
The responsibilities for this SOP are divided among various roles:
3.1 Change Control Board (CCB):
Responsible for reviewing and approving proposed changes.
3.2 Change Initiators:
Responsible for initiating change requests and providing necessary documentation.
3.3 Department Managers:
Responsible for implementing approved changes within their departments.
4) Procedure
4.1 Change Initiation:
4.1.1 Identify the need for a change and complete a Change Request Form.
4.1.2 Provide a detailed description of the proposed change, including its impact on product quality, safety, efficacy, and regulatory compliance.
4.1.3 Obtain approval from the Change Initiator’s supervisor.
4.2 Change Evaluation:
4.2.1 Review the proposed change by the Change Control Board (CCB).
4.2.2 Evaluate the impact of the change on processes, procedures, equipment, and documents.
4.2.3 Assess the risk associated with the change using risk assessment tools.
4.3 Change Approval:
4.3.1 Obtain approval for the change from the Change Control Board (CCB).
4.3.2 Document the approved change and notify relevant
4.3.3 Develop an implementation plan for the approved change.
4.4 Change Implementation:
4.4.1 Implement the approved change according to the developed implementation plan.
4.4.2 Verify and validate the effectiveness of the change.
4.4.3 Document all activities related to change implementation.
4.5 Change Review and Closure:
4.5.1 Review the implemented change to ensure it meets intended objectives.
4.5.2 Close the change request and update relevant documents and records.
4.5.3 Conduct post-implementation review to assess the effectiveness of the change.
5) Abbreviations, if any
CCB – Change Control Board
6) Documents, if any
1. Change Request Form
2. Change Evaluation Report
3. Change Approval Documentation
4. Implementation Plan
5. Post-Implementation Review Report
7) Reference, if any
1. FDA Guidance on Change Control
2. ICH Q10 Pharmaceutical Quality System
8) SOP Version
Version 1.0