Understanding coolchain component qualification

Have you got it covered?
With the growing number of pharma transport events being affected by unwanted temperature excursions, there is an urgent need to improve temperature management during product distribution.

The following series of insightful articles takes its inspiration from the White Paper published by DuPont™ Tyvek®, titled ‘Have you got it Covered?’ We will examine the process of coolchain component qualification in the context of thermal protection and overall transport qualification.

Week 1
This week we endeavour to summarise the challenges and answer the question: Why is coolchain route qualification needed?

The manufacture of pharmaceuticals is a global business. With a number of regulated quality control measures now in place, in particular the EUs Good Distribution Practice (GDP), there is a critical need for a structured approach to the validation of the components and solutions used in transporting pharmaceutical products.

Of particular concern is Controlled Room Temperature (CRT) logistics, also known as controlled ambient temperature. The nominal CRT temperature band of 15º to 25º covers a large proportion of the finished pharmaceuticals that are transported across the world and thus there is a pressing need to put in place CRT management systems that are dependable, effective and affordable.

We need certainty, consistency and control. However this is often difficult when the majority of the distribution/logistic operations are carried out by outsource parties. It is therefore essential that systems are in place throughout the distribution chain as part of an overall coolchain qualification programme.

Why it’s needed
Firstly, regulatory obligations make it necessary for producers to validate and qualify cool chains. They need to demonstrate that necessary controls are in place, ultimately ensuring patient safety.

Secondly, there are a number of weak links in the pharma cool chain, from manufacturer to consignee. Moving pharma products has the potential to affect a product, either making it less effective or even dangerous, so we need to control this risk.

Thirdly, the pharma producers bear a responsibility, both legally and morally, to ensure appropriate control measures are enforced – they can not simply pass on this responsibility along the supply chain. And indeed, if any organisation neglects product safety they are in breach of the law.

By specifying the service levels required from 3PLs and by participating in key component validations and the development of qualified shipping routes, a pharma company is able to exercise control of its transport lanes, supported by documented evidence.

Click here to view Week 2 – Coolchain Product Qualification

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