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In this blog a high-level introduction is given to technology transfer in pharmaceutical manufacturing. Technology transfer is the collaborative process for the directed dissemination of scientific findings, knowledge and intellectual property from the inventors to a receiving party. Specifically in pharmaceutical industry it plays an important role within product life cycle management, from drug discovery […]

Introduction In this blog post, our colleague Lars Pinxten, lead auditor with +10 years of experience in the pharmaceutical industry, takes you through the challenging world of auditing. From understanding the concept of first, second and third party audits to sharing practical tips and tricks for a successful audit. Why Audits? Audits act as valuable

Internal audits – sometimes also called self inspections – are a crucial part of every Quality Management System. Sometimes they are perceived as a regulatory necessity only to comply with the Good Manufacturing Practices. However, it can be of very high value to your organisation if executed correctly. Understanding audits In the evolving landscape of

Introduction Believe it or not, the principles of Six Sigma can be applied to everyday life. In fact, you’re probably following some of them without even realizing it. During this journey, we’ll examine the DMAIC (pronounced as də-MAY-ick) strategy, a core aspect of Six Sigma. DMAIC is used to help solve problems and improve processes.

1.    Introduction In the fast-paced world of pharmaceuticals, staying up to date with the latest regulations and legislations is crucial. In the first halve of 2023, a draft version of new pharmaceutical legislation (Directive 2001/83 and Regulation 726/2004) has been unveiled, promising significant changes and advancements in the industry. In this blog, we’ll take a

Due to the growth of our company, we are entering some areas that are still uncharted territory for us. Questions like “How should we respond to a fire? How can we prevent workplace accidents? And how can we ensure that our employees work under ergonomic conditions?” are playing an increasingly crucial role. Did you know…

In the dynamic landscape of pharmaceuticals, ensuring product quality and patient safety is paramount. Quality Risk Management (QRM) stands out as a strategic approach that plays a pivotal role in achieving these objectives. Join me as we dig into the intriguing realm of QRM in the pharmaceutical sector.  Understanding Quality Risk Management QRM is not

After years of hard study, following an intense internship in the pharmaceutical industry, submitting your carefully prepared dossier to the Federal Agency for Medicines and Health Products, you do make a small dance of joy when you receive your mail approving your application to become a Qualified Person. You will also receive a unique tracking

Oligonucleotide drug development is considered as one of the top innovations within the pharmaceutical sector these days. Our QP consultant Thomas was involved as QA responsible within the project team of one of our customers in order to set up a robust and compliant platform to lyophilize oligonucleotide API’s. The overall goal was to support

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