Impact of possible removal of the Titanium dioxide from human medicines formulations […]
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.
Pharmacovigilance Data: challenges for Pharmaceutical Companies by: Daniela Rota PV Unit Manager […]
Covid-19 & Pharmaceutical manufacturing: the challenges for production quality, safety and continuity
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 by Alessio […]
Covid-19 vaccines supply chain has become a target for cybersecurity attacks. How […]
A snapshot of Serialization in Pharmaceutical Industry. by Danilo Neri, PQE Group […]
European Medicines Regulatory Network agreed to proceed with the extension of the Step 1 (risk evaluation) deadline to October 1st, 2020, due to Covid-19 spreading.
Nitrosamine Risk Assessment (Step 1): new deadlines for BIO and Chemical products […]