1 Identify the deviation

The first step in reporting a GMP deviation is to identify and document the deviation as soon as possible after it occurs or is detected. You should record the date, time, location, description, and impact of the deviation, as well as the name and signature of the person who identified it. You should also notify the relevant personnel, such as your supervisor, quality manager, or GMP coordinator, and isolate or quarantine any affected product or material.

2 Assess the deviation

The next step in reporting a GMP deviation is to assess the deviation to determine its severity, scope, and potential consequences. You should evaluate the deviation based on the risk it poses to product quality, safety, and efficacy, as well as to regulatory compliance, customer satisfaction, and business reputation. You should also consider the frequency, recurrence, and trend of the deviation, and whether it is related to any previous deviations or complaints.

3 Investigate the deviation

The third step in reporting a GMP deviation is to investigate the deviation to identify its root cause and contributing factors. You should use a systematic and structured approach, such as the 5 Whys, fishbone diagram, or fault tree analysis, to analyze the deviation and collect relevant data and evidence. You should also involve the appropriate cross-functional team members, such as production, quality, engineering, or maintenance staff, to provide their input and expertise.

4 Resolve the deviation

The fourth step in reporting a GMP deviation is to resolve the deviation by implementing corrective and preventive actions (CAPAs) to eliminate or reduce the root cause and prevent recurrence. You should define the CAPAs based on the findings and recommendations of the investigation, and assign them to the responsible persons with clear deadlines and expectations. You should also monitor and verify the effectiveness of the CAPAs and document the results and outcomes.

5 Report the deviation

The final step in reporting a GMP deviation is to report the deviation to the relevant internal and external stakeholders, such as senior management, quality assurance, regulatory authorities, or customers. You should prepare a deviation report that summarizes the deviation, its assessment, investigation, resolution, and any lessons learned or best practices. You should also follow the applicable reporting format, frequency, and requirements for your organization and industry.

6 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?