Standard Operating Procedure for Changeover Procedures

1) Purpose

The purpose of this SOP is to establish procedures for the effective and efficient changeover of equipment and processes to minimize downtime, reduce product variability, and ensure compliance with regulatory requirements.

2) Scope

This SOP applies to all changeover activities within the manufacturing facility that involve equipment, processes, or product lines.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Production Supervisor:

Responsible for coordinating and overseeing changeover activities.

3.2 Manufacturing Operators:

Responsible for executing changeover procedures as per established protocols.

3.3 Quality Assurance (QA) Personnel:

Responsible for verifying the completion and effectiveness of changeover procedures.

4) Procedure

4.1 Changeover Planning:

4.1.1 Schedule changeover activities based on production schedule and demand.
4.1.2 Develop a changeover checklist specifying tasks and responsibilities.
4.1.3 Obtain approval for changeover plan from Production Supervisor and QA.

4.2 Preparation for Changeover:

4.2.1 Clean equipment and work area thoroughly prior to changeover.
4.2.2 Gather necessary tools, materials, and components for changeover.
4.2.3 Perform equipment checks and verifications.

4.3 Changeover Execution:

4.3.1 Follow step-by-step procedures outlined in the changeover checklist.
4.3.2 Document each task completed during changeover.
4.3.3 Conduct in-process checks and verifications as required.

4.4 Post-Changeover Verification:

4.4.1 Verify equipment and process parameters post-changeover.
4.4.2 Perform validation checks to ensure product quality and compliance.
4.4.3 Obtain approval for completion of changeover from QA.

4.5 Documentation and Reporting:

4.5.1 Complete changeover documentation and update records.
4.5.2 Report any issues or deviations encountered during changeover.
4.5.3 Archive changeover records according to established document retention policies.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Changeover Checklist
2. Changeover Records
3. Validation Reports
4. Deviation Reports (if applicable)

7) Reference, if any

1. FDA Guidance on Changeover Procedures
2. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0