Standard Operating Procedure for Change Control Management

1) Purpose

The purpose of this SOP is to establish procedures for managing changes to processes, equipment, documents, and systems to ensure that changes are controlled and documented.

2) Scope

This SOP applies to all personnel involved in change control management at [Company Name] for the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Initiator: Proposing and documenting the change.
– Quality Assurance (QA) Department: Evaluating, approving, and monitoring changes.
– Relevant Departments: Implementing changes and ensuring compliance with approved procedures.

4) Procedure

4.1 Initiation of Change
4.1.1 Identify the need for a change in processes, equipment, documents, or systems.
4.1.2 Complete a Change Request Form, providing details of the proposed change and justification.
4.2 Evaluation of Change
4.2.1 QA to review the Change Request Form and evaluate the impact of the proposed change.
4.2.2 Conduct a risk assessment to determine the potential impact on product quality and regulatory compliance.
4.3 Approval of Change
4.3.1 QA to approve or reject the proposed change based on the evaluation and risk assessment.
4.3.2 Document the approval or rejection, including any conditions for approval.
4.4 Implementation of Change
4.4.1 Implement the approved change according to the documented plan.
4.4.2 Ensure that all affected personnel are trained on the new procedures or changes.
4.5 Verification of Change
4.5.1 Verify that the change has been implemented correctly and is functioning as intended.
4.5.2 Conduct any necessary testing or validation to confirm the effectiveness of the change.
4.6 Documentation
4.6.1 Maintain records of all change control activities, including Change Request Forms, risk assessments, approvals, and implementation details.
4.6.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Change Request Forms
– Risk Assessment Records
– Change Implementation Records

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0