Deviations investigations

 Deviations investigations refer to a process of identifying, evaluating, and addressing any deviations or variations from established procedures, processes, or specifications. Deviations can occur in any regulated industry, such as pharmaceuticals, biotechnology, medical devices, and food and beverage manufacturing, and can have significant consequences on product quality, safety, and efficacy.

The investigation process typically involves a thorough review of the deviation, including the root cause analysis and impact assessment. The investigation team may include representatives from various departments, such as quality assurance, manufacturing, engineering, and regulatory affairs, as well as subject matter experts.

The objective of the investigation is to determine the root cause of the deviation and to develop appropriate corrective and preventive actions (CAPAs) to prevent recurrence. The CAPAs may include changes to procedures, equipment, personnel, or training, as well as process improvements, design changes, or other corrective actions.

Deviation investigations are typically governed by standard operating procedures (SOPs) and regulatory requirements, such as good manufacturing practices (GMPs), good laboratory practices (GLPs), and other applicable regulations. It is essential to document the investigation process and to maintain accurate and complete records to demonstrate compliance with these requirements.

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