Audit - 04 Auditing a Deviation Management System

Audit Manual 04 - Auditing a Deviation Management System

Perform an audit of a deviation management system. Use a range of tools and information, including the contents of this unit to support the audit of a deviation management system. Understand and apply appropriate GMP standards/regulations.

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Audit 04 - Auditing a Deviation Management System



During manufacturing, unplanned events or incidents may occur. These events are considered deviations from established processes, procedures and policies possibly placing the product out of compliance with regulatory requirements and jeopardizing the safety, purity and effectiveness of the drug product.



Deviations may be referred to by many different names such as atypical events, discrepancies, problems, abnormal occurrences, events or incidents.



There must be a deviation management system in place to determine the extent of the deviation, the impact of the deviation and to investigate why the deviation occurred and what can prevent it from reoccurring.



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