Standard Operating Procedure for Change Control in Aerosol Production
1) Purpose
The purpose of this SOP is to establish a controlled and documented process for managing changes in aerosol production. This ensures that all changes are evaluated, approved, and implemented in a way that maintains product quality and compliance with regulatory requirements.
2) Scope
This SOP applies to all changes affecting the production of aerosols at [Company Name], including changes to equipment, processes, raw materials, facilities, and documentation.
3) Responsibilities
Change Control Committee (CCC): Review and approve proposed changes.
Initiator: Submit change request and provide necessary documentation.
Quality Assurance (QA) Manager: Ensure changes are evaluated for impact on product quality and regulatory compliance.
Department Managers: Evaluate the impact of changes on their respective areas and ensure proper implementation.
4) Procedure
4.1 Initiation of Change:
4.1.1 The initiator identifies the need for a change and completes a Change Control Request (CCR) form.
4.1.2 The CCR form should include a description of the change, rationale, impact assessment, and supporting documentation.
4.1.3 Submit the CCR form to the QA Manager for preliminary review.
4.2 Preliminary Review:
4.2.1 The QA Manager reviews the CCR form for completeness and initial assessment of impact.
4.2.2 If the change is minor and does not affect product quality, the QA Manager may approve the change directly.
4.2.3 For significant changes, the QA Manager forwards the CCR form to the Change Control Committee (CCC) for further evaluation.
4.3 Evaluation by Change Control Committee:
4.3.1 The CCC evaluates the proposed change for potential impact on product quality, regulatory compliance, and other critical areas.
4.3.2 The CCC may request additional information or a risk assessment to better understand the implications of the change.
4.3.3 The CCC approves, rejects, or requests modifications to the proposed change.
4.4 Implementation of Approved Changes:
4.4.1 Once approved, the initiator coordinates the implementation of the change according to the agreed-upon plan.
4.4.2 Update relevant documentation, such as SOPs, batch records, and validation protocols, to reflect the change.
4.4.3 Train personnel on the new procedures or equipment as necessary.
4.5 Post-Implementation Review:
4.5.1 After the change has been implemented, the QA Manager conducts a review to ensure that the change has been executed correctly.
4.5.2 Monitor the impact of the change on product quality and process performance through follow-up testing and audits.
4.5.3 Document the outcomes of the post-implementation review and update the change control records.
5) Abbreviations, if any
CCC: Change Control Committee
CCR: Change Control Request
QA: Quality Assurance
SOP: Standard Operating Procedure
6) Documents, if any
Change Control Request (CCR) Forms
Change Control Records
Risk Assessment Reports
Updated SOPs and Batch Records
7) Reference, if any
GMP Guidelines
ICH Q10 Pharmaceutical Quality System
FDA Guidance for Industry: Change Control
8) SOP Version
Version 1.0
