Blog

This story is about our project with Libbs Farmacêutica to successfully apply a QbD framework in the development of an oral drug product

In this blog post, we will give you all the steps about how to create a PACM protocol and how ICH Q12 supports you in it.

The EU has released its GMP Annex 1 revision after 14 years of development! This blog post gives a few ideas on how to apply it more easily.

In this blog post, we talk about how can you implement Risk Management Processes for Cell and Gene Therapies to every aspect of your product.

The new ICH Q14 guideline is here! How to implement it? We talked with Jean-François Dierick and Claudia Magagnoli on how they did it at GSK.

Assuring business continuity in pharma can be complex. Effective risk management strategies can help you operate during disruptions.

Using QRM within a Lifecycle Management framework ensures consistency at all levels where modern pharma operations are concerned.

Tech Transfer is especially important. When switching facilities, you want to transfer the knowledge and reproduce the process smoothly.

There are still some challenges when it comes to minimizing the risks in Cell and Gene Therapy. Here, we give some thoughts on how to manage and minimize them.

In this blog post, we tell what the most effective approach for your biosimilars approval to reduce its time to market is.

Continuous Manufacturing brings quality and delivery many business gains when applied to biologic products.

A blog post about applying digital transformation to the QRM of the top-tiers of the Pharmaceutical Companies and how it can benefit them.

This is a post about optimising a perfusion cell culture, using a combination of Root Cause Anlysis and Corrective and Preventive Action.

A blog post where we give you some tips on how Quality Risk Management can help you improve your Medical Cannabis business

ATMPs are a field that is new, complex, and specific. Having a digital QRM System for ATMPs can have a strong impact in your operations.