What is a deviation in GLP and how should it be handled?

• A. A minor data entry error that is ignored if unimportant.
• B. An approved alteration to the protocol.
• C. An unplanned divergence from the protocol; it should be documented, investigated, and actions taken to minimize impact, potentially with CAPA.
• D. A change in study personnel.

Answer: (C)

In GLP, a deviation is an unplanned divergence from the approved study protocol, SOPs, or study plan. It happens when something occurs that wasn’t anticipated and could affect how the study is conducted or how the data are generated. The right way to handle it is to document it immediately in the deviation log or study file, then notify the Study Director and Quality Assurance. Next comes an assessment of the deviation’s impact on study conduct, data integrity, and participant safety. An investigation should identify root causes and contributing factors, and determine whether the affected data are still valid or if retesting, redoing procedures, or data exclusion is needed. Actions to minimize impact are implemented, and a corrective and preventive action (CAPA) plan may be developed to address the root cause and prevent recurrence. Depending on the risk, you may need to inform the study sponsor and regulatory authorities and ensure proper records and approvals are in place. After implementing the CAPA, the deviation is closed with evidence that the issue has been resolved. This differs from approved protocol changes, which are formal amendments, and from changes in study personnel, which are staffing matters handled through separate processes.