Critical Utilities GMP Compliance and new Annex 1

New Annex 1, among other important points considered, dedicates several comments on the importance and the impact of Critical Utilities, involved at different level either because directly impacting on Contamination Control Strategy (CCS) document, or because potential direct or indirect source of bio-contamination of the final product.

EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers

EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers by Danilo Maruccia, Executive Consultant & Business Partner – PQE Group As EU MDR 2017-745 Regulation deadline is approaching, cybersecurity for Medical Devices has become a main concern for all Networked Medical Devices manufacturing companies. In the video below, we’ll review the most important requirements […]

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 “Risk Based approach to Qualification Activities” free Webinar by PQE, on April 20th@ 10 a.m. CET. Register now to secure your presence. Introduction After a […]

A snapshot of serialization . PQE Group Insights - Pharmaceutical

A snapshot of Serialization in Pharmaceutical Industry

A snapshot of Serialization in Pharmaceutical Industry. by Danilo Neri, PQE Group VP Operations & Partner Most of the regulated agencies have established serialization and aggregation in order to fight counterfeiting and to enhance the level of control of the entire supply chain related to pharmaceutical Products.

PQE Group - Infodemic Project - How the COVID-19 crisis differs from the economic crisis in the past

How the Covid-19 crisis differs from the economic crises in the past?

How the Covid-19 crisis differs from the economic crises in the past? by PQE Group’s Infodemic Research Team Topic: Social Economy Researchers: Ana Luisa Moreira, Consultant Abstract Humankind has experienced several difficult periods in recent history, some of which lead to an economic crisis. This study aims to compare two of the economic crises of […]

Nitrosamines impurities risk evaluation

Nitrosamine – Risk Evaluation: new deadlines for BIO and Chemical products announced

Nitrosamine Risk Assessment (Step 1): new deadlines for BIO and Chemical products announced by PQE Group As indicated in the latest updates on HMA.eu official website, the deadlines for Nitrosamine Risk Evaluation (STEP 1), formerly set on October 1st 2020 due to COVID-19 outbreak, have been newly updated as following: March 31st for Chemical medicines. […]

PQE Group - Infodemic Project - How Government Policies affect the number of COVID 19 infections worldwide

How Government Policies affect the number of COVID 19 infections worldwide? – a Case Study

How Government Policies affect the number of COVID 19 infections worldwide? – a Case Study by PQE Group’s Infodemic Research Team Topic: Mathematical Models Researchers: Dario Garcea, Consultant Miguel Angel Andrade Moreno, Senior Consultant Different government approaches and their consequences Abstract The COVID 19 is a pandemic influencing the human health and economy at a […]