Recent world events have been showing pharma companies the importance of having an effective business continuity plan (BCP). Risk management is a crucial part of the business continuity plan, but it can be a challenge for the pharma industry, given the complexity of the supply chains. One example that is Read more…
Making Post-Approval Changes can be a challenge. You have different timelines, different submission requirements and trouble optimising your processes. Because of that, this makes the knowledge of creating a post-approval change management (PACM) protocol all the more important. And that’s what this blog post is all about! In it, we’ll Read more…
Subjectivity in Risk Assessments and Quality Risk Management (QRM) outputs has been under the spotlight recently. In this post we will explore why, how, and what are the tools that you can use to minimize it. Current regulatory context Since the publication of ICH Q9 in 2005, it became the Read more…
With a new guidance on Data Integrity (DI) being prepared by the World Health Organization (WHO) to replace its previous one, this is a good time to look at Data Integrity in Healthcare! On that note, keep in mind that regulatory agencies also have their own guidelines: European Medicines Agency Read more…
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…