How can you write and review GMP change control documents?

1 Define the change

The first step in writing a change control document is to define the scope, objective, and rationale of the change. You should clearly describe what is changing, why it is changing, how it will affect the current state, and what are the expected benefits and risks of the change. You should also identify the relevant stakeholders, such as the change owner, the change initiator, the change approver, and the change implementer, and their roles and responsibilities. The change definition should be concise, accurate, and complete.

2 Assess the impact

The next step in writing a change control document is to assess the impact of the change on the quality, safety, efficacy, and regulatory aspects of the product or process. You should consider the potential effects of the change on the product specifications, the process parameters, the validation status, the equipment qualification, the facility layout, the documentation system, the training requirements, and the regulatory submissions. You should also identify any pre-requisites or dependencies that need to be completed before or after the change. The impact assessment should be objective, systematic, and comprehensive.

3 Plan the implementation

The third step in writing a change control document is to plan the implementation of the change. You should define the actions, resources, timelines, and deliverables that are required to execute the change. You should also specify the acceptance criteria, the verification methods, and the closure procedures that will confirm the effectiveness and completeness of the change. The implementation plan should be realistic, feasible, and measurable.

4 Review and approve

The final step in writing a change control document is to review and approve the document. You should ensure that the document is consistent, clear, and compliant with the applicable GMP standards and guidelines. You should also verify that the document has been reviewed and approved by the appropriate stakeholders, such as the quality assurance, the engineering, the production, and the regulatory affairs departments. The review and approval process should be timely, thorough, and documented.

5 Follow up and monitor

After writing and approving a change control document, you should follow up and monitor the implementation of the change. You should communicate the change to the relevant personnel, provide the necessary training and support, and update the affected documents and records. You should also monitor the performance and outcomes of the change, collect and analyze the data, and report any deviations or issues that may arise. The follow up and monitoring process should be continuous, proactive, and responsive.

6 Learn and improve

The last step in reviewing a change control document is to learn and improve from the experience. You should evaluate the results and feedback of the change, identify the best practices and lessons learned, and share the knowledge and insights with others. You should also recognize the achievements and challenges of the change, celebrate the successes and address the gaps, and initiate any corrective or preventive actions that may be needed. The learning and improvement process should be collaborative, constructive, and adaptive.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?