44 - Preparing for Regulatory Inspections (S19E6)

26 min • 24 maj 2025

Provide guidance on preparing for regulatory inspections by detailing strategies for organizing documentation, training personnel, and performing mock audits. Emphasize what inspectors are looking for during the audit and who to work with them. Also underscore that it's a way to look at improving and growing the quality of production.

Explain the importance of transparency, effective communication, and proactive identification of potential gaps prior to an inspection, and emphasize best practices for interacting with inspectors and using inspection outcomes to drive continuous improvement in GMP compliance and operational excellence. Discuss the steps for a proper response if the inspection finds an area of failure. Also the appropriate and best practices.