Olivier

External Audit Through the Optimistic Lens of a QA Consultant

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

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GAMP® 5: Insights from the 2nd Edition Update – The Key to Successful Validation and CSV

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

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Consultants: who and what?

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

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PUPSIT (part 2/2)

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

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PUPSIT (part 1/2)

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

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