This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and reference.

"The only way to be able to protect patients from substandard and falsified medical products is that each and every part of the manufacturing and supply chain is aware of its own influence on the quality of a medicinal product ... by preventing any negative influence of the quality, efficacy or safety ... and assuring that the medicinal product stays within the legal supply chain."

From the text Foreword by Lea Joos, Government of Upper Bavaria

Get current by reading this reprint and the additional 25 other timely and informative chapters to be found in Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volumes 1 and 2, edited by Siegfried Schmitt. Description details, a complete Table of Contents and details about purchase of the two volume set will be found at: go.pda.org/GDP1 and go.pda.org/GDP2

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Table of Contents:

• Good Cold Chain Management Practices for Controlled Room Temperature Shipments
• Chain of Custody Gap
• Regulatory Environment
• Good Cold Chain Management Practices for Controlled Room Temperature Shipments
• Conclusion
• References

About the Author

Steve Winyard works for Cryo Logistics Solutions Group, Airgas Healthcare in the US. He is a passionate highly strategic and commercially competent pharmaceutical cold chain logistics and supply chain professional with over two decades of blended executive-level, leadership experience in commercial operations, temperature controlled supply chain and logistics operations.