Deviation SOP

Deviation Management

The purpose of such Deviation SOP is to ensure that all Deviations are documented, investigated within 30 working days, assessed by the responsible line units and Quality Assurance (QA), corrective actions if applicable are implemented and implementation is tracked, the complete process is managed, monitored and controlled.

The procedure should be applicable to all GxP manufacturing and quality operations including development processes manufacturing clinical trail materials, toxicity testing and stability studies. All deviation investigations must be conducted and documented on the attached deviation form or in a related and validated computerized system.