How to perform a robust Vaccine Technology Transfer in a challenging era
Operational Technology and Cyber Security must walk hand in hand by Danilo Maruccia […]
Technology Transfer has always been a hot topic and can be even more challenging for complex processes/products like biotechnological ones.
In this Covid-19 pandemic era, different companies are facing technology transfer processes as a mandatory way to boost their covid vaccines production and follow patients’ need, shifting a series of contract manufacturers across the world that must inherit their technology and achieve compliance in a really short timing to meet the production goals.
New EU GMP Annex 1 – Implications for QRM application by Alessio […]
Covid-19 vaccines supply chain has become a target for cybersecurity attacks. How […]
The second draft of GMP Annex 1 has been recently released and the issue date for the new revision is finally approaching. The document, a milestone standard for all sterile manufacturers, has been widely revised and extended.
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.
Why MD Cybersecurity is so important by Danilo Maruccia, Executive Consultant & […]
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.