Unmasking the truth behind Human Errors – A Closer Look at Pharmaceutical Industry Pitfalls

Introduction In the vast realm of pharmaceuticals, where precision and accuracy are paramount, human errors can have far-reaching consequences. These errors encompass a spectrum of mistakes, from mislabeling medications to miscalculating dosages, each bearing the potential to impact patient safety, regulatory compliance, and a company’s reputation.  This blog post delves into the multifaceted nature of …

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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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