Standard Operating Procedure for Change Control in Manufacturing Processes

1) Purpose

The purpose of this SOP is to establish procedures for initiating, evaluating, implementing, and documenting changes to manufacturing processes to maintain product quality, safety, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the initiation, assessment, and implementation of changes to manufacturing processes within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Change Control Board (CCB)

• Evaluate and approve change requests based on defined criteria.
• Monitor implementation and effectiveness of approved changes.

3.2 Manufacturing and Quality Assurance (QA) Teams

• Assess impact of proposed changes on product quality and compliance.
• Implement changes according to approved procedures.

4) Procedure

4.1 Change Initiation

1. Submit change request detailing proposed changes and rationale.
2. Assign unique change control number and classification.

4.2 Change Evaluation

1. Conduct impact assessment on product quality, safety, and regulatory compliance.
2. Review and approve change request by CCB.

4.3 Change Implementation

1. Develop implementation plan and timeline.
2. Communicate approved changes to relevant departments.
3. Update relevant documentation (e.g., SOPs, batch records).

4.4 Change Review and Closure

1. Verify effectiveness of implemented changes through review and monitoring.
2. Close change request and update change control log.

5) Abbreviations, if any

SOP: Standard Operating Procedure; CCB: Change Control Board; QA: Quality Assurance

6) Documents, if any

• Change Request Form
• Change Impact Assessment Reports
• Updated SOPs and Batch Records

7) Reference, if any

ICH Q10: Pharmaceutical Quality System
FDA Guidance for Industry: Change Control Procedures

8) SOP Version

Version 1.0