Change Control Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for managing changes to processes, equipment, or procedures to ensure that all changes are properly evaluated, documented, and implemented without negatively impacting product quality.

2) Scope

This SOP applies to all changes affecting the manufacturing processes, equipment, procedures, or systems within the pharmaceutical manufacturing facility.

3) Responsibilities

– Department managers are responsible for initiating change control requests.
– QA personnel are responsible for evaluating, approving, and overseeing the implementation of changes.
– QC personnel are responsible for verifying that changes do not adversely affect product quality.

4) Procedure

1. Initiating Change Control
1.1. Identify the need for a change in processes, equipment, or procedures.
1.2. Complete a Change Control Request Form detailing the proposed change, its rationale, and potential impact.
1.3. Submit the completed form to the QA department for initial review.
2. Preliminary Evaluation
2.1. QA personnel conduct a preliminary evaluation of the proposed change to assess its potential impact on product quality, regulatory compliance, and business operations.
2.2. If the change is deemed significant, proceed with a formal risk assessment.
3. Risk Assessment
3.1. Conduct a risk assessment to identify potential risks associated with the proposed change.
3.2. Use appropriate risk assessment tools such as Failure Mode and Effects Analysis (FMEA) or Hazard Analysis and Critical Control Points (HACCP).
3.3. Document the findings and mitigation measures in the Risk Assessment Report.
4. Approval Process
4.1. Review the Change Control Request Form, Risk Assessment Report, and any supporting documentation.
4.2. QA personnel, along with relevant stakeholders, approve or reject the proposed change.
4.3. Document the approval decision and any conditions for implementation.
5. Implementation
5.1. Develop an implementation plan detailing the steps required to execute the change.
5.2. Communicate the approved change and implementation plan to all affected departments.
5.3. Execute the change according to the plan, ensuring minimal disruption to operations.
6. Verification and Validation
6.1. Perform verification and validation activities to ensure the change has been implemented correctly and does not adversely affect product quality.
6.2. Document the results of verification and validation activities.
7. Documentation
7.1. Update all relevant documentation, including SOPs, batch records, and equipment logs, to reflect the approved change.
7.2. Maintain a comprehensive Change Control Log to track all change control activities.
8. Review and Approval
8.1. Submit the Change Control Log and supporting documentation to the QA department for final review.
8.2. QA will review and approve the documentation, ensuring that all necessary actions have been taken and that the change has been properly managed.

5) Abbreviations, if any

– QA: Quality Assurance
– QC: Quality Control
– FMEA: Failure Mode and Effects Analysis
– HACCP: Hazard Analysis and Critical Control Points
– SOP: Standard Operating Procedure

6) Documents, if any

– Change Control Request Form
– Risk Assessment Report
– Change Control Log

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– ICH Q10 – Pharmaceutical Quality System

8) SOP Version

Version 1.0