Covid Vaccine Technology Transfer: 5 reasons, risks, good practices

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.

ICSR pharmaco vigilance data challenges

ICSR and Pharmacovigilance Data: Challenges for Pharmaceutical companies

Pharmacovigilance Data: challenges for Pharmaceutical Companies by: Daniela Rota PV Unit Manager & GVP Compliance Advisor @ PQE Group Marianna Esposito GCP Unit Manager, GCP Advisor & Auditor @ PQE Group Francesco Abbate CSV/CSA & Data Integrity Advisor @ PQE Group Pharmaceutical companies are asked every day to collect pharmacovigilance data in a structured format […]

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.

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.

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. […]

The art of working after Covid-19: a positive side effect from Covid-19

The art of working after Covid-19: a positive side effect from Covid-19 by Danilo Maruccia and Pierre Crivelli Last decade brought market evolution with itself, and a race for research and development to increase opportunities, optimize costs and improve efficiency in the way leaders do business and manage their companies. This heritage comes from 2008 […]