Equipment Logbooks: Good Practices and Regulatory Requirements

All major GMP guidelines including US FDA, EU GMP and Schedule M have clear requirements on logbook usage and recording of events. While proper recording can support data integrity in many ways, Improper use and event recording can lead to regulatory observations and warning letters. Adoption of simple processes in this module can improve the organization’s overall GMP compliance. ​ This course covers fundamental GMP requirements related to documentation and is one of the fundamental GMP training for everyone involved in GMP and supporting operations like R & D and process development. ​