How do you record GMP deviations and corrective actions?

1 Identify the deviation

The first step in recording a GMP deviation is to identify the deviation as soon as possible and report it to the responsible person or department. You should describe the deviation in detail, including what happened, when, where, how, and why. You should also include any relevant information, such as batch number, product name, equipment used, personnel involved, and any observations or measurements. You should use objective and factual language and avoid assumptions or opinions.

2 Assess the impact

The next step in recording a GMP deviation is to assess the impact of the deviation on the product quality, safety, and efficacy. You should consider the potential risks and consequences of the deviation, such as product contamination, non-conformance, customer complaints, or recalls. You should also evaluate the severity and frequency of the deviation, as well as the extent of the deviation from the specifications, standards, or procedures. You should use a risk-based approach and document your rationale and evidence for the assessment.

3 Implement immediate actions

The third step in recording a GMP deviation is to implement immediate actions to contain, correct, or mitigate the deviation. You should identify and document the actions taken, such as isolating the affected product, stopping the process, adjusting the parameters, or notifying the customers. You should also verify and document the effectiveness of the actions taken, such as testing the product, inspecting the equipment, or reviewing the records. You should ensure that the actions taken are appropriate, timely, and traceable.

4 Investigate the root cause

The fourth step in recording a GMP deviation is to investigate the root cause of the deviation. You should use a systematic and structured method, such as the 5 Whys, fishbone diagram, or fault tree analysis, to identify and document the underlying factors that contributed to the deviation. You should consider all possible causes, such as human error, equipment failure, material defect, or process variation. You should also collect and document any relevant data, records, samples, or interviews that support your analysis.

5 Define corrective actions

The fifth step in recording a GMP deviation is to define corrective actions to prevent the recurrence of the deviation and to eliminate its root cause. You should use a SMART (specific, measurable, achievable, relevant, and time-bound) approach to identify and document the corrective actions, such as revising the procedures, training the staff, repairing the equipment, or changing the suppliers. You should also assign and document the responsibilities, resources, and deadlines for implementing the corrective actions.

6 Monitor and close

The final step in recording a GMP deviation is to monitor and close the deviation record. You should follow up and document the status and completion of the corrective actions. You should also verify and document the effectiveness of the corrective actions, such as conducting audits, reviews, or validations. You should ensure that the deviation record is complete, accurate, and approved by the authorized person or department. You should also update and document any changes in the quality system, such as policies, manuals, or records.

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?