Deviation management refers to the process of identifying, analyzing and documenting the causes of deficiencies, deviations and OOS results that occur during the manufacture and quality control of pharmaceutical products. The goal of deviation management is to identify the causes of a problem and prevent the problem from recurring. This is an important element of the pharmaceutical quality system and GMP requirements.

The most important steps in the investigation of deviations:

• Identifying the deviation: The deviation (German translation: Abweichung) is documented and a preliminary description of the problem is prepared. Deviations are defined as manufacturing defects, equipment failures, non-compliance with process parameters or out-of-specification results (OOS).
• Primary impact analysis: Evaluation of the impact of a deviation on product quality and determination of its severity (e.g. critical, major or other; German translations: kritisch, schwerwiegend, sonstig).
• Root cause analysis (German translation: Ursachenanalyse): Use of methods such as the five whys method or the Ishikawa diagram to determine the cause of a deviation. This analysis includes a review of any factors that could have caused the deviation, including human error, processes, equipment and environmental conditions.
• Definition and implementation of CAPA (corrective and preventive actions; German: Korrektur- und Vorbeugemaßnahmen): Based on the results of the investigation, measures are developed to eliminate the causes of the deviation and prevent it from recurring.
• Documentation and compilation of a report: All steps of the investigation including the causes, the corrective measures taken and their results are recorded in a deviation report. The documentation must be properly prepared and stored for future analysis or audits.
• Monitoring and evaluating the effectiveness of CAPAs: The results of the corrective and preventive actions are evaluated in order to ensure that the problem has been fully resolved and will not recur.

The importance of deviation management:

• Guarantee of product quality and safety: Deviation management helps to identify and rectify problems at an early stage, minimizing risks to drug quality and patient safety.
• Compliance with regulations: Properly conducted deviation investigations are a GMP standards requirement and ensure compliance with regulatory requirements.
• Process optimization and prevention of repeated deviations: By analyzing the causes of deviations and implementing CAPAs, production processes can be improved and the likelihood of similar deviations recurring can be reduced.

Deviation management therefore plays a central role in quality systems. It allows for continuous monitoring of production processes, improves the sustainability of the quality system and promotes compliance with GMP standards in the pharmaceutical industry.

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