What are the best practices for addressing GMP deviations in batch records?

2 Investigate the root cause

The second step is to investigate the root cause, which is the underlying reason or factor that led to the deviation. You should use a systematic and structured approach, such as the fishbone diagram, the 5 whys, or the fault tree analysis, to identify and analyze the root cause. You should also collect and review all the relevant data and evidence, such as batch records, test results, observations, interviews, and audit reports.

3 Implement corrective and preventive actions

The third step is to implement corrective and preventive actions, which are the actions taken to correct the deviation and prevent its recurrence. You should define the actions, responsibilities, and timelines, and document them in the batch record. You should also verify and validate the effectiveness of the actions, and monitor their implementation and outcomes. You should also update the procedures, specifications, or instructions as needed to prevent similar deviations in the future.

4 Report and communicate the deviation

The fourth step is to report and communicate the deviation, which is the process of informing and involving the relevant stakeholders, such as the quality assurance, quality control, production, regulatory affairs, and management. You should report the deviation, its root cause, and its corrective and preventive actions in a clear and concise manner, and follow the internal and external reporting requirements and guidelines. You should also communicate the deviation, its impact, and its lessons learned to the relevant personnel, and provide feedback and training as needed.

5 Review and evaluate the deviation

The fifth step is to review and evaluate the deviation, which is the process of assessing and improving the deviation management system. You should review the deviation, its causes, its actions, and its outcomes, and evaluate their effectiveness, efficiency, and compliance. You should also identify and address any gaps, weaknesses, or opportunities for improvement in the deviation management system, and implement continuous improvement measures.

6 Document and archive the deviation

The sixth step is to document and archive the deviation, which is the process of maintaining and storing the deviation records. You should document all the information and data related to the deviation, its causes, its actions, and its outcomes, in a consistent and traceable manner. You should also archive the deviation records in a secure and accessible location, and retain them for as long as required by the GMP standards and regulations.

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?