From Concept to Medicine - A Comprehensive Drug Development Journey

33 – The Role of GMP Audits in Ensuring Compliance (S18E1)


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This episode introduces the critical world of Good Manufacturing Practice (GMP) audits. We'll explore the core objectives of these audits, differentiating between internal, external, and supplier audits and how each plays a vital role in maintaining quality. Discover how these systematic assessments verify compliance with Current Good Manufacturing Practice (cGMP) standards, going beyond simple checklists to uncover hidden weaknesses in processes. Emphasis is placed on the significance of these audits in driving continuous improvement within organizations.

We delve into how GMP audits facilitate not just the identification of problems, but also the implementation of effective solutions. Learn about the crucial role of detailed audit documentation in tracking progress and ensuring accountability. We'll highlight the importance of corrective action follow-ups, and how audits contribute to fostering a culture of quality that permeates every level of an organization, ensuring that quality management systems operate effectively and efficiently. Ultimately, protecting the consumer.

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From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

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