Standard Operating Procedure for Change Management in Aerosol Production
1) Purpose
The purpose of this SOP is to establish procedures for initiating, documenting, evaluating, implementing, and verifying changes to processes, equipment, facilities, materials, or documentation in aerosol production. Effective change management ensures controlled and compliant modifications while minimizing risks to product quality and safety.
2) Scope
This SOP applies to all change management activities related to aerosol production processes at [Company Name], including changes initiated through CAPA, deviations, improvements, and continuous improvement initiatives.
3) Responsibilities
Change Control Board (CCB): Evaluate and approve/reject change requests based on impact assessments.
Quality Assurance (QA) Manager: Oversee change management procedures and ensure compliance with regulatory requirements.
Production Supervisor: Initiate change requests and provide necessary documentation and justification.
Quality Control (QC): Assess impact of changes on product quality and verify effectiveness of implemented changes.
4) Procedure
4.1 Change Initiation:
4.1.1 Identify and document the need for change, including rationale, scope, and potential impact on product quality, safety, and regulatory compliance.
4.1.2 Complete the Change Request Form (CRF) with details such as proposed change, reason for change, and expected outcomes.
4.2 Change Evaluation:
4.2.1 Submit CRF to the Change Control Board (CCB) for evaluation and initial assessment.
4.2.2 CCB reviews CRF to determine the impact of the proposed change on processes, product quality, regulatory compliance, and other relevant factors.
4.2.3 Conduct risk assessment if necessary to evaluate potential risks associated with the proposed change.
4.3 Change Approval:
4.3.1 Based on CCB evaluation, approve or reject the change request.
4.3.2 If approved, assign responsibilities for implementing the change and establish a timeline for implementation.
4.3.3 Document CCB decisions and rationale for approval/rejection.
4.4 Change Implementation:
4.4.1 Develop and execute an implementation plan for the approved change.
4.4.2 Communicate change details to affected personnel and provide necessary training or instructions.
4.4.3 Monitor and supervise the implementation process to ensure adherence to the approved plan.
4.5 Change Verification:
4.5.1 Verify the effectiveness of implemented changes through validation, testing, or other verification activities.
4.5.2 Document verification results and ensure that implemented changes achieve intended outcomes.
4.5.3 Obtain final approval from CCB or designated authority to confirm closure of change request.
4.6 Documentation:
4.6.1 Maintain comprehensive records of change requests, evaluations, approvals, implementation plans, and verification activities.
4.6.2 Archive change management documentation in a controlled documentation system for traceability and regulatory inspections.
4.6.3 Review and update SOPs based on insights gained from change management activities and continuous improvement initiatives.
5) Abbreviations, if any
SOP: Standard Operating Procedure
CCB: Change Control Board
QA: Quality Assurance
QC: Quality Control
CRF: Change Request Form
6) Documents, if any
Change Request Form (CRF)
Change Control Board Meeting Minutes
Change Implementation Plan
Verification and Validation Records
7) Reference, if any
ICH Q10: Pharmaceutical Quality System
ISO 13485: Medical devices – Quality management systems
FDA Guidance for Industry: Change Control – Implementation and Documentation
8) SOP Version
Version 1.0
