Implementing a World Class Deviation Management

Excerpt from the GMP Compliance Adviser

In spite of qualified equipment, trained employees and validated processes, the daily routine in pharmaceuticals is rife with situations in which prescribed workflows are not observed or processes fail to deliver the expected results. For this reason it is important not only to define the workflows for production in "normal cases", but also to specify how such deviations are to be handled. This will ensure that acceptable product quality can be obtained even in the event of unforeseen circumstances.

You will learn all you need to know about

• Requirements for deviation management
• Workflow of deviation management
• Responsibilities
• Failure investigation report
• Evaluations
• Review of the system effectiveness
• Interfaces to the CAPA system
• Examples
• Quotes from regulatory works