How can you prioritize and categorize deviations in your GMP process?

1 Why prioritize and categorize deviations?

Prioritizing and categorizing deviations is essential for managing them effectively and efficiently. By prioritizing deviations, you can allocate your resources and time to the most critical issues that pose the highest risk to the product and the patient. By categorizing deviations, you can apply consistent and appropriate criteria for determining the root cause, the corrective and preventive actions (CAPA), and the reporting and escalation requirements. Prioritizing and categorizing deviations also helps you monitor and measure the performance and compliance of your GMP process and identify areas for improvement.

2 How to prioritize deviations?

One way to prioritize deviations is to use a risk assessment tool that evaluates the severity and probability of the deviation and its impact on the product quality attributes and the patient safety. For example, you can use a risk matrix that assigns a numerical score or a color code to each deviation based on its risk level. The higher the risk score or the darker the color, the higher the priority of the deviation. You can also use a risk ranking that classifies deviations into high, medium, or low priority based on predefined criteria and thresholds. The higher the priority, the more urgent and rigorous the investigation and CAPA should be.

3 How to categorize deviations?

Another way to categorize deviations is to use a classification system that defines the type and scope of the deviation and its relation to the specifications and standards. For example, you can use a classification scheme that distinguishes between critical, major, and minor deviations based on the degree of deviation from the expected or acceptable results and the potential impact on the product quality and patient safety. The more severe the deviation, the more serious the classification. You can also use a classification system that differentiates between product-related, process-related, equipment-related, and human-related deviations based on the source or cause of the deviation. The different categories of deviations may require different levels of investigation, CAPA, and reporting.

4 How to document deviations?

Documenting deviations is a key step in managing them and ensuring traceability and accountability. You should document deviations using a deviation report or a deviation form that captures the essential information about the deviation, such as the date, time, location, description, product, batch, personnel, and equipment involved. You should also document the risk assessment, the classification, the investigation, the CAPA, and the verification and closure of the deviation. You should follow the standard operating procedures (SOPs) and the good documentation practices (GDPs) for documenting deviations and maintaining accurate and complete records.

5 How to prevent deviations?

Preventing deviations is the ultimate goal of managing them and improving your GMP process. You can prevent deviations by implementing effective CAPA that address the root cause of the deviation and prevent its recurrence or occurrence of similar deviations. You can also prevent deviations by conducting regular training and refresher courses for your personnel, performing routine maintenance and calibration of your equipment, reviewing and updating your SOPs and specifications, and conducting internal and external audits and inspections of your GMP process. You should also monitor and review the trends and patterns of deviations and use them as inputs for continuous improvement and risk management.

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?