From Concept to Medicine – A Comprehensive Drug Development Journey
This episode focuses on the execution of a GMP audit, outlining the best practices that ensure a thorough and effective assessment. Learn about the key techniques employed by auditors, including structured interviews with personnel, comprehensive record reviews, and direct on-site observations. We explore how auditors navigate complex processes and documentation to identify deviations from established standards. Discover the importance of clear communication between auditors and the auditee, fostering a collaborative environment.
We'll discuss how auditors use a systematic approach to evaluate compliance. Learn the importance of maintaining objectivity throughout the audit, ensuring unbiased assessment of the facility's operations. We emphasize the crucial role of detailed note-taking, accurately capturing audit findings for subsequent analysis and corrective actions. Ensuring that audits are fair, objective, and contribute to meaningful improvements.
En liten tjänst av I'm With Friends. Finns även på engelska.