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Handling of Out of Specification (OOS) results

Introduction As described in cGMP regulations (21 CFR 211.160 & 211.165), laboratory testing of components, containers & closures systems, in-process materials, bulk- and finished products is mandatory to ensure product quality and patient safety. Tests will be performed as described in previously defined specifications, and if a result falls outside of the specification limits or […]

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Maximizing Excellence – The Importance of Annual Product Quality Reviews

In the dynamic landscape of pharmaceutical manufacturing, ensuring quality, safety and efficacy of medicines is key. One of the tools to ensure this is the Annual Product Quality Review (APQR also known as APR or PQR), it is a critical process mandated by regulatory authorities and embraced by industry leaders. In this blog we delve

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Technology Transfer in Pharmaceutical Manufacturing

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

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The Art of Auditing in the Life Science Industry: An In-Depth Look through the Eye of a Lead Auditor

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

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Internal audits

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

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Unlocking Success for your professional and personal life? DMAIC Problem-Solving Methodology to the rescue!

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.

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A Glimpse into the Future: Exploring the Latest Draft of Pharmaceutical Legislation

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

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Navigating Quality Risk Management in the pharmaceutical industry

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

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