The Cell and Gene Therapies industry is growing at a tremendous speed, building both on innovative solutions and a solid investment by life science companies who wish to diversify their market offer. The results have been impressive and Patients who had exhausted treatment options are getting exciting new opportunities. To Read more…
The execution of Risk Assessment for Nitrosamine Impurities is still a hot topic, and it’s not going to cool down any time soon. Back in June 2018, a Chinese API manufacturer notified EU authorities that N-nitrosamines were identified in a batch of valsartan. Nitrosamines are a genotoxic and carcinogenic agent Read more…
In this article we will discuss the ever growing importance of Quality Risk Management in the context of Lifecycle Management. Risk and knowledge management were introduced by the ICH guidelines (ICH Q8 onwards). Since then, they became increasingly appreciated and implemented through other guidance such as the EU-GMP Guidelines. The forthcoming ICH Read more…