Global Cold Chain Connections Posts
When it comes to active versus passive shipping containers, the top three considerations when determining which is best for your cold cha...
Clinical trial material (CTM) or investigational medicinal products (IMP) are an important part of the early stages of the life science supply chain. As trials are being run on a global scale, in markets with less than ideal infrastructure, there is a dire need for companies to work with specialized cold chain experts to engineer and design innovative distribution processes.
Cold chain failure may lead to: the patient being administered an unsafe product; liability based on compliance infractions; inconsistent data results; or an entire shipment’s product integrity could be rejected by the quality department, resulting in costly delays.
Documentation strategy for your cold chain management validation practices has evolved over the last several years. The FDA and other regulatory agencies are requesting more and more specific information in the filing to confirm the impact to drug...
The selection process of passive shippers intended to maintain a specified range of temperatures from the point of ori...
Cold chain specialist Gary Hutchinson provides his predictions for 2016 within cold chain:Specialized packaging and network designs for specific drugsWe are seeing a trend in
Process validation for cold chain logistics (
Stability testing outlined in the ICH guidelines primarily addresses the establishment of expiry dating and storage conditions. Temperature-sensitive product may exceed long-term storage conditions established by the...
A drug can take a variety of paths from the manufacturer to the patient. Most often, the product leaves the manufacturer's direct control and enters a complex system of handoffs (see chart from US Pharmacopoeia). Distribution systems that deliver...
Today’s Pharmaceutical Cold Chain Network is Increasingly Complex and Involves Many Players
Published: 2015-04-08
Published: 2015-04-08
Competing priorities, changing expectations, cost pressures, sustainability initiatives, emerging markets -- these are the challenges facing cold chain management professionals every day. Solutions that deliver value in the supply chain and enhanc...
