Standard Operating Procedure for Change Management in Gels Production
1) Purpose
The purpose of this SOP is to establish procedures for initiating, evaluating, approving, implementing, and documenting changes in gels production processes, ensuring controlled and systematic management of changes to maintain product quality, safety, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s gels production department, including Quality Assurance (QA), Quality Control (QC), Production, Engineering, and Regulatory personnel responsible for change management activities.
3) Responsibilities
Quality Assurance (QA) Team: Oversee change management process and ensure compliance with SOPs.
Quality Control (QC) Analysts: Assess impact of changes on quality control testing and specifications.
Production Supervisors: Implement approved changes in production processes.
Engineering Team: Evaluate equipment-related changes and ensure compliance with engineering controls.
Regulatory Affairs: Ensure changes are documented and communicated in accordance with regulatory requirements.
4) Procedure
4.1 Change Initiation
4.1.1 Identify and document proposed changes to gels production processes, equipment, materials, or facilities.
4.1.2 Classify changes based on type (e.g., process change, equipment change, formulation change) and impact assessment criteria.
4.2 Change Evaluation and Impact Assessment
4.2.1 Assess potential impact of proposed changes on product quality, safety, efficacy, and regulatory compliance.
4.2.2 Perform risk assessment to determine risks associated with the proposed changes.
4.3 Change Approval
4.3.1 Obtain approval for proposed changes from designated personnel, such as Change Control Board or designated approvers.
4.3.2 Document change approval including rationale, assessment findings, and approval signatures.
4.4 Change Implementation
4.4.1 Develop and implement an implementation plan for approved changes, including timelines, responsibilities, and validation requirements.
4.4.2 Communicate change details to relevant departments and personnel affected by the change.
4.5 Change Verification and Validation
4.5.1 Verify and validate implemented changes through testing, validation studies, or other verification activities as required.
4.5.2 Document verification and validation results, ensuring compliance with regulatory requirements and internal standards.
4.6 Change Documentation and Reporting
4.6.1 Maintain comprehensive documentation of all change management activities, including change requests, assessments, approvals, implementation plans, and verification/validation results.
4.6.2 Report significant changes to regulatory authorities as required by applicable regulations.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
6) Documents, if any
– Change Request Form
– Change Impact Assessment Reports
– Change Approval Records
– Change Implementation Plans
– Change Verification and Validation Reports
7) Reference, if any
– FDA Guidance for Industry: Process Validation: General Principles and Practices
– ICH Q10: Pharmaceutical Quality System
– Company-specific change control procedures and guidelines
8) SOP Version
Version 1.0