LOGISTICS TECHNICAL AGREEMENTS

Many transport services in the distribution and supply of medicinal products are carried out by external logistics service providers, and many other activities in the GDP environment are often outsourced also. In this context, the question arises on when is it necessary to sign a Technical/Quality Agreement? Which regulatory requirements apply? and which aspects should be covered in such an agreement?..

Temporary Regulatory Flexibilities

In its Inspectorate Blog the MHRA published a post on temporary changes in Good Distribution Practice (GDP) entitled “How to manage temporary GDP process changes and risks through the COVID-19 pandemic”…

MESOTHELIOMA – Continued

A few years ago, I submitted a blog about Mesothelioma, an aggressive cancer that is typically caused by the inhalation or ingestion of microscopic asbestos fibres – and how this was being contracted by people exposed to those asbestos fibres years, in fact, decades, later. Furthermore, I tried to explain how it’s used in the construction industry had been negligently prolonged, the numbers of people affected, and its non-curable devastation. Mesothelioma, and related Asbestos-linked conditions, were supposed to reach a peak in 2020, so I wanted to see what progress has been made in treatment, awareness and compensation. I was quite surprised by what I found.

MHRA SYMPOSIUM 2018

The MHRA GDP Symposium heralds the end of the year and the opportunity to mull over any advice on Regulatory changes and Inspectorate trends. The chance for clarity and what will be expected for (very) near future changes to trading laws and status –  especially...

What do you want to do?

What do you want to do? Provide Information. When do you want to give it to us? Ummmm… OK, you might have been more definite in your final answer. But was it what the MHRA Inspector wanted to hear? Or see in your SOP’s? Particularly with regards to information on...