Details and explains the enforcement mechanisms that regulatory agencies employ to make sure cGCP compliance. Also explained is the role that audit procedures, risk-based inspections, and corrective actions have.

This includes the ways that all of the previous measures drive continuous improvement and to safe guard participant safety in clinical research. Discussions on good documentation practices will take place, the types of audits are performed, and the role they take in maintaining GCP compliance. Validation practices tie into many aspects of CGMP, and will be discussed in full detail.