Standard Operating Procedure for Change Control Management in Otic Manufacturing Unit
1) Purpose
To establish procedures for managing changes in processes, systems, equipment, and documentation within the Otic manufacturing unit to ensure controlled implementation, evaluation, and communication of changes.
2) Scope
This SOP applies to all changes initiated within the Otic manufacturing unit, including but not limited to processes, equipment, facilities, materials, and documentation.
3) Responsibilities
Change Control Board (CCB): Responsible for evaluating and approving/rejecting change requests.
Quality Assurance (QA) Department: Responsible for oversight and ensuring compliance with change control procedures.
Department Heads: Responsible for initiating and implementing changes within their respective departments.
4) Procedure
4.1 Change Request Initiation
4.1.1 Request Submission
4.1.1.1 Initiate a change request using the designated form or electronic system.
4.1.1.2 Provide detailed information including rationale, scope, and potential impact of the change.
4.1.2 Review and Classification
4.1.2.1 QA reviews the change request for completeness and accuracy.
4.1.2.2 Classify the change request based on its significance and impact (e.g., major, minor, administrative).
4.2 Change Evaluation
4.2.1 Impact Assessment
4.2.1.1 Assess potential impact of the change on product quality, safety, efficacy, and regulatory compliance.
4.2.1.2 Determine if additional testing, validation, or documentation is required.
4.2.2 Risk Assessment
4.2.2.1 Conduct risk assessment to identify and mitigate potential risks associated with the change.
4.2.2.2 Document risk assessment findings and mitigation strategies.
4.3 Change Approval
4.3.1 CCB Review
4.3.1.1 Present change request to the Change Control Board (CCB) for review and approval.
4.3.1.2 CCB evaluates impact, risks, and supporting documentation before making a decision.
4.3.2 Approval Notification
4.3.2.1 Communicate CCB decision to stakeholders and update change status in the change control system.
4.3.2.2 Obtain necessary approvals before implementing the change.
4.4 Change Implementation
4.4.1 Implementation Plan
4.4.1.1 Develop an implementation plan outlining tasks, timelines, and responsibilities.
4.4.1.2 Ensure adequate resources and training are provided for change implementation.
4.4.2 Execution
4.4.2.1 Implement the approved change as per the established plan and procedures.
4.4.2.2 Monitor and document implementation activities.
4.5 Post-Implementation Review
4.5.1 Effectiveness Assessment
4.5.1.1 Evaluate the effectiveness of the change in achieving its intended objectives.
4.5.1.2 Address any issues or deviations observed during or after implementation.
4.5.2 Closure
4.5.2.1 Close the change request in the change control system after successful implementation and review.
4.5.2.2 Archive documentation related to the change for future reference.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
CCB: Change Control Board
6) Documents, if any
Change request form
Risk assessment template
Implementation plan
7) Reference, if any
GMP guidelines for change control in pharmaceutical manufacturing
8) SOP Version
Version 1.0
