Deviation management refers to the structured process for identifying, documenting, investigating, and correcting deviations that occur during the manufacturing, testing, or quality control of pharmaceuticals. This process is crucial to ensure the integrity and quality of products and compliance with regulatory requirements.
Deviation management includes the following steps:
- Detection: Identification of a deviation from the standard procedure or specification.
- Documentation: Written record of the deviation, including its details and potential impacts.
- Investigation: Analysis of the causes of the deviation to determine the origin and reasons.
- Corrective Actions: Implementation of actions to address the immediate impacts of the deviation.
- Preventive Measures: Introduction of measures to prevent the recurrence of the deviation.
- Review and Closure: Evaluation of the effectiveness of the actions taken and formal closure of the deviation.
Effective deviation management is crucial for maintaining regulatory compliance and continuously improving product quality.