Standard Operating Procedure for Change Control in Creams Production
1) Purpose
The purpose of this SOP is to establish procedures for initiating, documenting, evaluating, and implementing changes in creams production processes, equipment, facilities, or materials to maintain product quality, safety, and regulatory compliance.
2) Scope
This SOP applies to all changes affecting creams production activities, including but not limited to formulations, manufacturing processes, equipment, facilities, and personnel.
3) Responsibilities
It is the responsibility of the Change Control Board (CCB), comprising representatives from quality assurance, production, regulatory affairs, and other relevant departments, to review and approve change requests.
Production personnel are responsible for initiating change requests and providing necessary documentation.
4) Procedure
4.1 Change Request Initiation
4.1.1 Identify and document the need for change, including rationale and potential impact on creams production.
4.1.2 Complete a Change Request Form detailing proposed changes, justification, and anticipated outcomes.
4.1.3 Obtain endorsement from relevant personnel or departments affected by the change request.
4.2 Change Evaluation
4.2.1 Submit the Change Request Form to the Change Control Board (CCB) for evaluation and review.
4.2.2 Evaluate the proposed change based on its impact on product quality, safety, efficacy, regulatory compliance, and validation status.
4.2.3 Conduct risk assessment to identify potential risks associated with the change and propose mitigation measures.
4.3 Change Approval
4.3.1 The CCB reviews the Change Request Form, assessment findings, and proposed mitigation measures.
4.3.2 Approve or reject the change request based on evaluation outcomes and risk assessment.
4.3.3 Obtain written approval from the CCB before implementing approved changes.
4.4 Change Implementation
4.4.1 Develop and execute an implementation plan for approved changes, including timelines, responsibilities, and validation requirements.
4.4.2 Update relevant documents, such as SOPs, batch records, and training materials, to reflect approved changes.
4.4.3 Conduct training sessions for personnel involved in implementing or affected by the change.
4.5 Change Closure and Documentation
4.5.1 Verify successful implementation of approved changes through verification activities, including validation studies or testing, as applicable.
4.5.2 Close out the Change Request Form once all change-related activities are completed and verified.
4.5.3 Maintain comprehensive documentation of all change-related activities, approvals, and verifications.
5) Abbreviations, if any
CCB: Change Control Board
SOP: Standard Operating Procedure
6) Documents, if any
Change Request Form
Change Control Board Meeting Minutes
Change Implementation Plan
Verification and Validation Reports
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0