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 evaluation findings and recommendations.
4.3.3 Document CCB decisions and communicate approval to relevant stakeholders.
4.4 Change Implementation:
4.4.1 Develop and execute an implementation plan for approved changes.
4.4.2 Notify affected personnel of change implementation and provide necessary training.
4.4.3 Conduct verification and validation activities as required.
4.5 Change Closure and Documentation:
4.5.1 Verify completion and effectiveness of implemented changes.
4.5.2 Close change control record and update documentation as necessary.
4.5.3 Archive change control records according to established document retention policies.
5) Abbreviations, if any
CCB – Change Control Board
QA – Quality Assurance
6) Documents, if any
1. Change Control Request Form
2. Change Evaluation Report
3. Change Implementation Plan
4. Change Control Records
7) Reference, if any
1. FDA Guidance for Industry: Changes to an Approved NDA or ANDA
2. ICH Q10 Pharmaceutical Quality System
8) SOP Version
Version 1.0
