Good Distribution Practices and Audit Readiness

This week, Stacey welcomes back Siegfried Schmitt to the show. Stacey and Siegfried discuss the complexities in supply chain management, the expectations for a GDP audit, and deficiencies in distribution processes. Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry. Just like in other areas of drug manufacture, there is an expected dedication to quality and compliance, which should be present in every aspect of distribution. It is the responsibility of the drug company to comply with distribution requirements including storage and transport of their products, ensuring its safety and security throughout the supply chain.

About Our Guest:

Siegfried Schmitt

Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems, including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity, and Supply Chain, as well as a trusted expert for regulatory, compliance, and industry-best-practices projects. Siegfried has more than 30 years of experience in the healthcare industry, spanning manufacture, analytics, validation, and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland, and is a Fellow of the Royal Society of Chemistry.

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