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, […]
November 28, 2024
Published by Joachim Nuyttens at November 28, 2024
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Training day

This Tuesday, we had an engaging and insightful training day at Trevalco! Our consultants participated in a variety of sessions:Pharmaceutical Packaging led by Marleen ClynhensIT Infrastructure by Laetitia TardifEquipment Qualification and Sterilization Validation with Jolanda Muurman Our expert trainers delivered high-quality, interactive sessions that catered to both our junior and senior consultants. Their expertise and energy made the day a valuable learning experience for everyone!
November 8, 2024
Vincent junior consultant GMP
Published by Joachim Nuyttens at November 8, 2024
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Colleague in the Spotlight – Vincent

Vincent is one of our junior consultants. Graduated Master in Biochemistry and Biotechnology, he has been working for two years as a consultant in GMP production environments. His first assignment was as project engineer on aseptic (sterile) production plants, a few months ago he started his second assignment at Trevalco as production engineer. In this short interview, we let Vincent talk about the content of his duties as a production engineer. What are your main duties as a production engineer? […]
October 24, 2024
Brent voor als validatie consultant een P&ID walkdown uit
Published by Joachim Nuyttens at October 24, 2024
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Colleague in the Spotlight – Brent

Brent is one of our junior consultants. With three years of validation experience in GMP production environments, he has a lot of practical and theoretical knowledge about cleaning validation and sterilization validation. In this short interview, we let Brent talk about the content of his duties as a validation consultant. What are your main tasks as a validation consultant? My tasks are very diverse and in fact almost every task within the validation life cycle is equally important. As soon […]
October 14, 2024
QC lab hplc
Published by Harris Bui-Vandeput 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 Harris Bui-Vandeput 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 30, 2024
Published by Joachim Nuyttens at September 30, 2024
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Spartacus Run 2024

This past weekend, four enthusiastic colleagues from Trevalco tackled the AA Drink Spartacus Run in Boom, one of Belgium’s most challenging and exciting obstacle races. Set in the scenic but demanding terrain of De Schorre, this event saw participants navigate a course filled with mud, water, and tough obstacles spread across 10 km. Despite the chilly weather, spirits were high as the Trevalco team confronted obstacles such as towering climbs, muddy trenches, and even sections requiring swimming. The race, known […]
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