October 5, 2025
Published by Joachim Nuyttens at October 5, 2025
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Wouter and Ilke presenting at ISPE

Last week our colleagues Wouter Van Beylen and Ilke Diels presented at the ISPE CQV and Emerging Leaders event organised on the site of MSD Boxmeer, Netherlands. They shared their expertise on Cleaning Validation. It was a great presentation for a full conference room, confirming Wouter and Ilke’s experience in cleaning validation.
June 12, 2025
Published by Joachim Nuyttens at June 12, 2025
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Reflecting on The Past six Months: The Launch of Our HVAC / Testing Team

Since January, we have been proud to offer specialized services in HVAC and cleanroom testing. Our dedicated team of technicians and engineers is equipped to handle balancing, testing of HVAC installations, and commissioning and qualification activities for HVAC and cleanrooms, adhering to standards such as ISO 14644. As we approach the six-month mark, it’s a good time to reflect on this journey and our achievements. The Beginning In December 2024, we made the decision to launch our new team. With […]
December 5, 2024
Published by Joachim Nuyttens at December 5, 2024
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Deviations: Understanding OOS, OOT, and OOE in Pharmaceutical QC Laboratories

In the pharmaceutical and life sciences industries, product quality and patient safety are paramount. But what happens when processes don’t go according to plan? Managing deviations—unexpected events that diverge from approved standard operating procedures (SOPs), guidelines, or specifications—is crucial for maintaining compliance, quality, and safety throughout manufacturing, distribution, storage, and testing.  A deviation can occur when a parameter, measurement or analytical result exceeds a defined threshold, signalling a potential risk. Addressing these issues promptly and effectively is essential to prevent […]
December 2, 2024
Lab Technician evaluation environmental monitoring data
Published by Joachim Nuyttens at December 2, 2024
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Real-Time Environmental Monitoring: a Recent Innovation in Sterile Manufacturing

The pharmaceutical industry is undergoing a transformation, driven by the latest updates to GMP regulations like Eudralex Annex 1. This evolution demands more robust and efficient environmental monitoring solutions, particularly in the manufacturing of sterile medicinal products. One of the most promising advancements in this field is Real-Time Environmental Monitoring (RTEM), which provides continuous insights into air quality and contamination risks, ultimately enhancing compliance and operational efficiency.  The Need for Real-Time Monitoring  Traditionally, environmental monitoring (EM) has relied on growth-based methods, […]
October 14, 2024
QC lab hplc
Published by Joachim Nuyttens at October 14, 2024
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What is Quality Control (QC)

Quality Control (QC) is the department which ensures that the incoming materials, products, utilities and cleanrooms are of sufficient quality for their use. The importance of QC stems from the undeniable obligation to deliver quality product that guarantees patient safety. Therefore, the need of a QC department has been made compulsory by several regulations including the EudraLex’s guidelines for GMP and FDA’s 21 CFR.   As the name suggests, the quality of incoming material, products, cleanrooms and utilities is verified in […]
October 7, 2024
Root Cause Analysis
Published by Joachim Nuyttens at October 7, 2024
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Root Cause Analysis

In the pharmaceutical industry, quality isn’t just a goal—it’s a requirement. To meet the high standards of safety and effectiveness, companies must continually address and resolve any deviations, product defects, or unexpected issues that arise. Enter Root Cause Analysis (RCA)—a structured approach that digs deep to uncover the underlying cause behind these problems.  RCA is essential for several reasons. First and foremost, it protects patient safety. By identifying the root cause of deviations and other issues, companies can take the […]
September 24, 2024
Published by Joachim Nuyttens at September 24, 2024
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Can AI Chatbots Pass the GMP test? Insights for QA in Life Sciences

In this follow-up to our exploration of conversational AI, we dive deeper into the accuracy and effectiveness of popular AI chatbots like ChatGPT, Google Gemini, Meta AI, and Anthropic Claude when it comes to crucial QA tasks in Life Sciences. We put these AI tools to the test with tasks such as: While these chatbots show potential, particularly in tasks like pre-writing and document review, our evaluation found significant limitations—especially with fabricating information on GMP regulations. So, are AI tools […]
September 5, 2024
Published by Joachim Nuyttens at September 5, 2024
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Unlock the Power of Conversational AI in Life Sciences QA

In today’s fast-evolving Life Sciences sector, Quality Assurance (QA) Officers face increasing pressures to manage documentation, compliance, and operational processes. Could Conversational AI be a solution to enhance efficiency and accuracy? AI chatbots like ChatGPT, Microsoft Copilot, and Google’s Gemini are revolutionizing how professionals operate. These AI tools can assist in various ways, from summarizing complex regulatory documents to brainstorming solutions, editing reports, and even automating repetitive tasks. How Can Conversational AI Help Your QA Team? However, while AI offers […]
February 9, 2023
Published by Joachim Nuyttens at February 9, 2023
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From lab to life: AI trends in the Life Science industry

by Tom Oostvogels, Jr. Consultant at Trevalco Artificial Intelligence (AI) is all around us nowadays and it is starting to transform industries in all sectors. As such, AI is also finding its way to the life science industry and will help healthcare as we know it. The incorporation of Artificial Intelligence in life sciences has opened doors to new possibilities and has created new opportunities for innovation and growth. In this post, we’ll explore 5 of the latest trends in […]
November 16, 2022
Published by Joachim Nuyttens at November 16, 2022
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Trevalco Academy – online training

Our brand new Trevalco Academy is now live, offering online courses in validation, quality assurance and GMP compliance for the pharmaceutical industry. Trevalco Academy is our online training center through which anyone can subscribe to and follow digital, self-paced courses. We currently have 4 online trainings to offer, including two one-day trainings: We want to offer qualitative training at a reasonable price, which is possible because this is all training material we used at clients and for training of our […]
September 21, 2022
Published by Joachim Nuyttens at September 21, 2022
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What’s in the new Eudralex Annex 1

A few weeks back the new and final version of Eudralex Volume 4 Annex 1 “Manufacture of Sterile Medicinal Products” was published on the website of the European Commission. This new version will come into operation on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. Where the current version of Eudralex Volume 4 Annex 1 is 16 pages, the new version has no less than 59 pages. The new EU annex 1 regulation provides […]
November 16, 2021
Published by Joachim Nuyttens at November 16, 2021
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How to get more value from risk assessments in the life sciences industry

If you’re working in the life sciences industry you have probably been involved in risk assessments, maybe more often than you would have liked to. Whether you are working in a clinical development or pharmaceutical production environment, on drug products or medical devices, risk management has to be in place. This article will give you tips to make your risk assessments even better. One of the main reasons why risk assessments are so omnipresent is because in most cases they […]
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