New EU GMP Annex 1: Implications for QRM application

New EU GMP Annex 1 – Implications for QRM application by Alessio Rosati Sterility Assurance Executive Consultant – PQE Group The issues exposed in this article will be discussed in Contamination Control Strategy – Next year’s challenge for Pharma Quality Systems, from new EU GMP Annex 1″ free Webinar by PQE, next March 9th@ 10 […]

Windows 7 to 10 migration strategy

How to deal with Windows end-of-life

We consider the potential risks for Pharma and MD companies keeping their systems running on obsolete Windows versions and a good strategy to get up to date.

Cybersecurity for Medical Devices risks and vulnerabilities

Why MD Cybersecurity is so important

Why MD Cybersecurity is so important? PQE Group – 3/12/2019 The hidden risks of a disruptive innovation. Is Cybersecurity important for Medical Devices? The answer is absolutely yes. But let’s move a bit backwards, to understand the reason why nowadays Cybersecurity has become a main concern for all Medical Devices producers. It’s well renowned that […]

Nitrosamines impurities risk evaluation

CMDh raising risk awareness on Nitrosamine Impurities

On September 26th, 2019 the CMDh published the notice “Information on nitrosamines for marketing authorisation holders” asking to all Marketing Authorization Holders (MAHs) of human medicinal products containing chemically synthesised active pharmaceutical ingredients to evaluate the risk of the presence of nitrosamine impurities in their products. This includes generics and over-the counter (OTC) products.