Standard Operating Procedure for Change Control in Gels Production
1) Purpose
The purpose of this SOP is to establish procedures for initiating, evaluating, approving, and implementing changes to processes, equipment, facilities, and systems in gels production to ensure controlled and documented changes.
2) Scope
This SOP applies to all personnel involved in change control activities within the pharmaceutical manufacturing facility’s gels production department.
3) Responsibilities
Change Control Board (CCB): Evaluate and approve proposed changes based on impact assessments.
Quality Assurance (QA) Team: Ensure compliance with change control procedures and document changes appropriately.
Production Department: Implement approved changes and provide necessary training to personnel.
Engineering Department: Assess technical feasibility and impact of changes on equipment and facilities.
4) Procedure
4.1 Change Proposal
4.1.1 Identify and document the need for change, including rationale and potential impact.
4.1.2 Complete a Change Request Form detailing proposed changes and submit it to the CCB.
4.2 Change Evaluation
4.2.1 Review and assess the proposed change for its impact on product quality, safety, and regulatory compliance.
4.2.2 Conduct risk assessments, if necessary, to determine the level of validation and documentation required.
4.3 Change Approval
4.3.1 Present the change proposal to the CCB for evaluation and approval.
4.3.2 Obtain signatures and approvals from relevant stakeholders, including QA, Production, and Engineering.
4.4 Change Implementation
4.4.1 Develop an implementation plan specifying timelines, responsibilities, and validation requirements.
4.4.2 Execute the approved change in accordance with the implementation plan and document all activities.
4.5 Verification and Validation
4.5.1 Verify the effectiveness of the change through inspections, tests, or validation studies as required.
4.5.2 Validate changes that impact product quality or regulatory compliance before full implementation.
4.6 Documentation and Closure
4.6.1 Update relevant documents, including SOPs, batch records, and training materials, to reflect the approved change.
4.6.2 Close out the change request once all actions are completed and verified.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
CCB: Change Control Board
6) Documents, if any
– Change Request Form
– Change Control Log
– Change Implementation Plan
7) Reference, if any
– FDA CFR 21 Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q9: Quality Risk Management
– Company-specific change control procedures and policies
8) SOP Version
Version 1.0
