Standard Operating Procedure for Change Control Management
1) Purpose
The purpose of this SOP is to establish a procedure for managing changes to processes, procedures, equipment, and systems to ensure continued compliance with regulatory requirements and quality standards.
2) Scope
This SOP applies to all changes that may impact the quality of pharmaceutical products or compliance within the manufacturing facility.
3) Responsibilities
The responsibilities for this SOP are divided among various roles:
3.1 Change Initiators:
Responsible for proposing changes and providing necessary documentation and justification.
3.2 Change Control Committee:
Responsible for reviewing and approving proposed changes.
3.3 Quality Assurance (QA) Manager:
Responsible for overseeing the change control process and ensuring all changes are properly managed and documented.
4) Procedure
4.1 Identification and Documentation of Changes:
4.1.1 Identify changes that may impact product quality or compliance.
4.1.2 Document proposed changes using the Change Control Request Form.
4.1.3 Provide a detailed description of the change, including the rationale and potential impact.
4.2 Review and Approval of Changes:
4.2.1 Submit the Change Control Request Form to the Change Control Committee.
4.2.2 The Change Control Committee must review the proposed change to assess its impact on product quality and compliance.
4.2.3 Approve or reject the proposed change based on the assessment.
4.2.4 Document the decision and any conditions for approval.
4.3 Implementation of Approved Changes:
4.3.1 Implement approved changes according to the documented plan.
4.3.2 Update relevant documents, procedures, and systems to reflect the change.
4.3.3 Train personnel on the new procedures or changes as needed.
4.4 Verification and Documentation:
4.4.1 Verify that the change has been implemented correctly and is functioning as intended.
4.4.2 Document the implementation and verification process.
4.4.3 Review the change to ensure it has achieved the desired outcome without negative impact.
4.5 Post-Implementation Review:
4.5.1 Conduct a post-implementation review to evaluate the effectiveness of the change.
4.5.2 Document any issues or deviations observed during the review.
4.5.3 Make further adjustments if necessary to ensure the change meets quality and compliance standards.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
1. Change Control Request Forms
2. Change Control Logs
3. Post-Implementation Review Records
7) Reference, if any
1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ICH Q10 Pharmaceutical Quality System
8) SOP Version
Version 1.0
