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Everyone has without doubt heard of it by now – the so-called “miracle drug” for losing weight quickly, Ozempic® from the Danish company Novo Nordisk. This drug contains the active ingredient “Semaglutide” and is indicated for patients with type II diabetes. However, the drug is now regularly in the news because of its impending shortages […]

Our consultants Sofie and Thomas have been working on the implementation of electronic batch records for one of our customers over the past year. Also curious about their experiences? You can find out more below! What was your role within the project? Thomas: I was part of the project team as QA responsible. Within this

The announcement of an inspection by the Belgian Federal Agency for Medicines and Health Products (FAGG) or any other external audit within a pharmaceutical company is inevitably linked to extra workload and unwanted stressful situations. However, as a QA consultant at Farma Consultant & Partners, I’ve always viewed this as one of the most enriching

After 14 years, ISPE released the 2nd edition of the GAMP® 5 guide “A Risk-Based Approach to Compliant GxP Computerized Systems” in August 2022. While the core principles from the 1st edition remain valid, this update adds fresh insights to navigate the ever-evolving landscape of information technology within GxP environments. Additionally, it also expands on

A company can use the services of an external consultant when a certain expertise can’t be found within the team. Consultants are working on temporary projects, ranging from a few months to even years. Recent graduates, despite of expertise, can also work as a consultant. Important, in this case, is a great learning ability and

I started my QP certification and career at Pfizer Manufacturing NV in Puurs as Project Engineer in the chemical lab. I was responsible for analytical tech transfer and validation and for those of you, like my younger naïve self, who thought that those transfers and validations were always prosperous and efficient in such big pharmaceutical

A year ago, I graduated with a Master’s in Biomedical Sciences from KU Leuven. I often heard that this degree was highly valuable and offered numerous possibilities for my future career. One of those options was a job in the pharma and medical industry, but what did that entail, and how had my degree prepared

Completing a Master’s in Pharmaceutical Care or Drug Development opens up a world of possibilities. You might have considered working in a pharmacy, but that’s just the tip of the iceberg. Depending on your interests, various career paths await, each leading to different job opportunities (see Figure 1). If you’re exploring a career beyond the

My opinion on PUPSIT Despite my rather young QA career in aseptic pharmaceutical manufacturing, I have had the opportunity to work with both PUPSIT and non-PUPSIT filtration systems at multiple manufacturing sites. This allows me to get a good understanding of the real-life drawbacks and benefits of PUPSIT. My first job experience involved deviation handling

A standard for aseptic filling or a rare necessity? What is PUPSIT? In recent years, much discussion was raised on the need for pre-use/post-sterilization integrity testing (PUPSIT) of sterilizing filters to detect nonintegral filters before they are used for aseptic filling. The reasoning behind PUPSIT vs. a single post-use filter test is that there might