1) SOP for Change Control Procedures

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for requesting, evaluating, approving, and implementing changes to equipment, processes, or materials to ensure that all changes are properly controlled and documented in compliance with regulatory requirements.

3) Scope

This SOP applies to all personnel involved in the change control process within the pharmaceutical manufacturing facility.

4) Responsibilities

• Initiators are responsible for submitting change requests with sufficient detail and justification.
• Change Control Board (CCB) members are responsible for reviewing, evaluating, and approving or rejecting change requests.
• Quality Assurance (QA) personnel are responsible for overseeing the change control process and ensuring compliance with this SOP.
• Supervisors are responsible for implementing approved changes and verifying their effectiveness.

5) Procedure

1. Initiation of Change Request
   1. Identify the need for a change to equipment, processes, or materials.
   2. Complete a Change Request Form, providing details of the proposed change, including the rationale, impact assessment, and proposed implementation plan.
   3. Submit the Change Request Form to the QA department for initial review.
2. Initial Review by QA
   1. QA personnel review the Change Request Form for completeness and accuracy.
   2. If additional information is needed, QA personnel request it from the initiator.
   3. Once the Change Request Form is deemed complete, QA forwards it to the Change Control Board (CCB) for evaluation.
3. Evaluation by Change Control Board (CCB)
   1. The CCB, comprising representatives from relevant departments (e.g., QA, Production, QC, Engineering), reviews the Change Request Form.
   2. The CCB evaluates the potential impact of the proposed change on product quality, regulatory compliance, and manufacturing operations.
   3. The CCB may request additional information or clarification from the initiator if needed.
   4. The CCB decides to approve, reject, or request modifications to the proposed change.
   5. The decision and rationale are documented in the Change Request Form.
4. Implementation of Approved Change
   1. If the change is approved, the initiator develops a detailed implementation plan, including timelines, responsibilities, and any required training.
   2. The implementation plan is reviewed and approved by the CCB.
   3. The approved change is implemented according to the plan, with all activities documented.
5. Verification and Documentation
   1. Upon completion of the change implementation, QA personnel verify that the change has been implemented correctly and effectively.
   2. Any discrepancies or issues identified during verification are addressed promptly.
   3. All documentation related to the change, including the Change Request Form, implementation plan, and verification records, are archived in the change control logbook.
6. Post-Implementation Review
   1. The CCB conducts a post-implementation review to assess the effectiveness of the change and identify any further actions needed.
   2. Feedback from affected departments is collected and reviewed as part of the post-implementation assessment.
   3. The results of the post-implementation review are documented and used to improve future change control processes.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• CCB: Change Control Board

7) Documents, if any

• Change Request Form
• Change Control Logbook
• Implementation Plan
• Verification Records

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Company-specific change control guidelines

9) SOP Version

Version 1.0