UDI is a new system that assigns a unique barcode to each individual medical device. It will become mandatory when MDR and IVDR enter into force, so as a manufacturer, you need to make sure you’re UDI-ready in time.
During the QbD Corona World Games, our online international team building event, thirteen randomly selected teams defended their honor.
A short introduction and overview of the requirements In 2017, the European Commission released the new Medical Device Regulation (MDR) that will replace the Medical
One of our previous blogposts discussed innovations in the medical technology field and how these can fulfill unmet patients’ and physicians’ needs by leveraging the
Do you want to distinguish starting materials used for ATMPs from those used for transplants or transfusions? This distinction is made based on how the
Recently, we announced that Quality by Design and TRIUM Clinical Consulting have joined forces to create an end-to-end offering for the lifecycle of medical products
Among the Advanced Therapy Medicinal Products (ATMPs), in the immunotherapy market, nowadays two acronyms catch the eye: CAR-T and TCR-T. The two techniques are based
It’s obvious that product quality and patient safety are a top priority in the pharmaceutical industry. The quality by design methodology is used to build
GxP Processes Without question, the impact of GxP processes such as product quality and patient health are at the top of the list when it
What does an automation pyramid entail? An automation pyramid visualises the integrated layers of technology used in manufacturing or industry combined with the level of
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Have you read our earlier blogposts about the The importance of a dedicated team and skilled project manager for technology transfers, the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
Until now, academia and research-based companies have been the major source of successful ATMP (gene therapy and cell- or tissue-engineered product) developments. Based on their success, pharmaceutical companies are trying
In the first blog we discussed the definitions of validation and computerized systems. Checking the fitness of the system is to check whether the system operates according to the needs of the process for which it is acquired.
Checking your phone to see when you took your last medication? Your watch vibrating and telling you to lay down because you will have a seizure soon, while at the same time notifying your emergency contact with your exact location?
Have you read our earlier blogposts about the factors that can make or break your technology transfer, and the drivers of complexity in tech transfers?
Life sciences enterprises in for example the pharmaceutical, biotechnology and medical devices industry must validate computer systems that have an impact on the product and
On the 4th of May, it was the turn of Maaike Tuinsma (Pharmaceutical Consultant at QbD) to give the Biomedical Engineering students of the University of Liège a lecture. Topic of this week: FDA & Medical Devices.
In this blogpost, we will dive into these complexities a little bit more and provide you with some useful tips to minimise the complexity of your tech transfers.
Monday 27 April, the fourth QbD guest lecture was on the agenda for the Biomedical Engineering students of the University of Liège. This time the students were introduced to software as a medical device and validation & qualification by QbD’ers Bart Verlinden and Pieter Smits.
(This blog is part of a series. Want to read the first part? Check it out here) After the Easter holidays, QbD resumed its guest
A technology transfer can take place between buildings on the same production site, between different production plants from the same company or even between different
This blogpost aims to provide useful information for parties involved in the development of face masks in the fight against the COVID-19 pandemic. It lists
Innovation is key to the success of companies and is driving many industries. This is certainly true for the medical technology sector. According to yearly
A hiring freeze during Corona? No way! Although the current crisis has created new and unexpected challenges, QbD is not the kind of company to
As long as the COVID-19 measures are in place, the QbD recruitment team continues to work from home. But thanks to modern technology, and our
Hi! My name is Frederick Tison. I’m 26 years old and this is my third year at QbD. I’m currently active as a raw material
What is the definition of ATMP? From the website of EMA: Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on
The next episode in the guest lecture program for the students Biomedical Engineering at the University of Liège was a new experience for both trainers
As you know, QbD is a very sporty and healthy organization. Since today is the start of homework and social distancing week 2, we obviously
There we were, in the ‘quartier Polytech’, looking for the department ‘Aérospatiale & Mécanique’ at the university of Liège. We had gotten up way too
Advanced therapy medicinal products (ATMP) are cell and gene therapies that provide new opportunities for the treatment of a variety of diseases and injuries. Due
The past of Computer Systems Validation has served us well and provided us with the foundation of where we are today. But at some point, the past can become a burden. This is exactly the point in time where we have arrived.
As Production Support Engineer I support my client Biocartis with issues associated with the production process. Depending on the problem, it is my job to
The clock is ticking for Brexit. By 31 October 2019, a final agreement on the matter must be reached. There is no doubt that the UK leaving the European Union (EU) will have an enormous impact on the UK and EU member states.
When it comes to the market release of vaccines, there are some specific requirements and legislations that companies need to keep in mind. In this blog post, we will pay attention to the market release of vaccines onto two of the most important markets worldwide: the European Union and the United States of America. Although they are quite similar, there are some interesting differences when it comes to testing, documentation and certification.
It’s time again for a closer look into the daily life of another one of our QbD’ers! Meet Julie Bondroit, one of the members of
QbD is known for its team spirit and sporty character. This isn’t only the case at the office, but also outside of work!
s week, it’s pharmacist Evelyne Goudezeune’s turn to bring us along for a typical ‘Day in the QbD Life’, filled with several meetings and a very entertaining evening. Like what you read? Then make sure to send us your cv to join our amazing team
The manufacturing and sale of medicine is big business. As a result, falsified medicines are a serious threat to patients that are dependent of safe
Time to invade another QbDer’s privacy! In her ‘Day in the QbD life of…’, Lieve De Wolf gives us a closer look into a typical
Backed by increasing investments from commercial sponsors, the development of advanced therapy medicinal products (ATMP) is growing strongly in the United Kingdom. For good reason,
Imagine explaining the use of Excel and all its functions to someone who has never worked with the program before – in a written manual.
The qualification and validation group within QbD organized their first Competence Center a few weeks ago. This forum is used to discuss interesting topics concerning
Countries rely on the use of medical devices to achieve universal health coverage, respond to health emergencies and keep populations safe. We see companies designing
Wondering how a typical working day at Quality by Design looks like? In part 2 of our ‘A day in the QbD life of’ blog
How QbD puts the ‘play’ into ‘work, play, deliver’ – part 1 One upon a time, Martijn, one of QbD’s managing partners, had a brilliant
Advanced therapy medicinal products (ATMP) is the group of therapies in which we use cells, genes, engineered tissues and combinations of the above with medical
Want to know what a typical working day at Quality by Design looks like? In part 1 of our brand new ‘A day in the
Counterfeiting has always been a significant issue. While it might sound like a good deal when you can find your favorite brand of consumer good
After months of revision and many questions raised, it now appears that the time is coming to implement the new requirements contained in the revision
These past few days, the European Union’s lack of medical device regulation (MDR) has been highlighted by many news outlets. As a result, the Government
In recent years, 3D printing techniques have been revolutionising the healthcare industry everywhere in the world. 3D printing has the ability to print personalised medical
Several scientific and clinical breakthroughs of our past decade show that Advanced Therapy Medicinal Products (ATMP) will revolutionize 21st century medicine. By using cells as
On 20 December 2017, the European Medicines Agency (EMA) published the draft for the new EU GMP Annex 1 “Manufacture of Sterile Medicinal Products”. At
The Medical Devices landscape is subject to increasing standards and regulations. Though this may be perceived as a nuisance sometimes, it’s certainly no unnecessary luxury.
Medical Devices literally play a vital role in society. As they are key for healing patients and saving lives, they are subject to ever-increasing standards.
Of course, it’s vital for life sciences companies to comply with the highest quality standards. But many other sectors are also increasingly investing in quality
Data integrity is a cornerstone of scientific progress. However, a recent article in a leading Belgian newspaper shows that many researchers seem to tolerate violations
Every day, patients around the world participate in clinical trials. Their contributions are crucial, as they ensure the progress of vital research. However, research involving
Recently, UK’s MHPRA (Medicines and Healthcare Products Regulatory Agency) released a guidance document for data integrity in the pharma industry. The publication further emphasizes the
More than 10 years have passed since the last revision of Annex 1 of the EU GMP. On 20 December 2017, almost 3 years after
No need to ask Santa about GDP. Ask Sofie! GDP covers the crucial ‘last mile’ after production. It’s vital that patients receive their medication in
The Mutual Recognition Agreement between the US and the European Union is gradually taking effect. Since November 2017 FDA recognizes the regulatory authorities of 8
Day by day our consultants rely on very specific expertise and experience to meet the varying challenges of their clients. That is why proactivity is
In a world that is becoming more digital each day, the healthcare environment is facing complex challenges. It’s clear that healthcare companies will need to
Serialization is rapidly emerging in the pharmaceutical world. To fight counterfeit drugs, more and more governments demand that every single sales product gets a unique
Specialised trainings are one way in which we keep investing in the expertise of our QbD team. Three QbD colleagues share their views on the
Two recent FDA guidances In 2016 the U.S. Food and Drug Administration issued 2 very different guidance documents related to medical devices. One is software
A whole new era in healthcare is coming closer every day. Thanks to the crossover of 3D printing and biology, medical solutions will be personalised
Over the last couple of years, the data integrity topic has received more and more attention. Recently, the American Food and Drug Administration (FDA) issued
As a pharmaceutical project engineer at QbD, every day is different. Even more so when you visit a country very different from ours. Last month,
In the last three years, the life sciences industry has realized around 3,000 to 3,500 extra jobs in Belgium. This comes down to over 1,000
The latest developments in the market for orphan drugs are promising. In addition to the Netherlands and Luxembourg, the Flemish minister of public health Maggie
Clinical and pathological laboratories in the Netherlands are undergoing major changes. A growing number of them are applying for Dutch ‘Raad voor Accreditatie’ (RvA) accreditation
45,000 euros. It’s the fine pharmaceutical companies have to pay when they are unexpectedly unable to deliver certain medicines. The Dutch minister of Public Health,
Early November 2015, I set off for a ten day trip to Scandinavia. Main purpose of the trip? Checking on a completed filling and packaging
QbD supports HistoGeneX’ strong growth by optimizing computer systems HistoGeneX summons the assistance of Quality by Design, the expert in quality assurance for enterprises in
Process validation The process validation section has been doubled from 2 to 4 pages, with extra sections about verification of transportation, validation of packaging, qualification
When you say pharmacy, you say compliancy. Bringing new pharmaceutical products onto the market is subject to very strict rules regarding the development, manufacturing and
‘Opposites’: that’s the word that comes to mind when looking back on my four week adventure for QbD in the United States. Extreme opposites. In
On September 26th, 2012, the European Commission adopted a proposal for a regulation of the European Parliament and of the Council, to revise existing legislation
From 1 October 2015, the revision to Annex 15 of EudraLex Vol 4 comes into operation, qualification and validation. Annex 15 has been in effect
With winter on the way, the moment for a flu shot is at hand. A lot of people, often older than sixty or with a
Earlier this month, a team from QbD visited the Nordic Life Science Days in Stockholm, Sweden. The event would have been incomplete without QbD. Why?
Last March, the European Union published updated guidelines in the Eudralex – Volume 4: Good manufacturing practice (GMP) Guidelines. The chapters on Premise and Equipment,
Because, as time goes by, medicinal products for the European market are being produced increasingly outside Europe, EMA wants to write a new Guidance on
An excellent site for anyone looking for general GMP information or training ideas for GMP is the WHO (World Health Organization) website. The GMP information
At the end of last year the ICH published the harmonised Guideline For Elemental Impurities. This guideline sets out the PDEs (Permitted Daily Exposures) of
USP heeft op haar website 5 draft hoofdstukken gepubliceerd i.v.m. Good Distribution Practices (GDP) https://www.usp.org/usp-nf/notices/additional-feedback-sought-proposed-storage-and-distribution-general-chapters. Deze hoofstukken kwamen tot stand op basis van feedback van
Derde en laatste deel van over de FDA draft guidelines voor Combination products, met een korte bespreking van de 2 laatste hoofdstukken. Hoofdstuk 4: Extra
Na de bespreking van de eerste twee hoofdstukken eerder deze maand, vervolgen we met Hoofdstuk 3: General Considerations for CGMP Compliance: A. Demonstrating compliance: Hier
Valentijn vandaag, dus misschien kreeg je wel parfum of andere cosmetica cadeau, of heb je hiermee net je eega verrast. De veiligheid en kwaliteit van
FDA publiceert een Draft Guidance “Current Good Manufacturing Practice: Requirement for Combination products“. Op dit moment loopt de review, tot eind maart is het mogelijk
Medical devices in de US moeten voldoen aan de FDA Unique Device Identification (UDI) rule. Dit “UDI” is een uniek nummer, toegekend aan de meeste
Eerder dit jaar publiceerde EMA een revisie van de “Guideline on the acceptability of names for human medicinal products”. Voortaan kunnen bij een nieuwe indiening
Zeker geen reden tot ongerustheid voor gebruikers en producenten, maar EMA, de European Medicines Agency, is gestart met de review van Ibuprofen bevattende medicijnen. Dit
ANDA staat voor Abbreviated New Drug Application. Een ANDA is een dossier dat wordt ingediend bij de FDA voor een generische variant op een al
Aangezien EMA het in de Q&A lijst heeft toegevoegd, zal het wel een vraag afkomstig uit de industrie zijn: “Is het acceptabel om een extra
Voor wie er behoefte aan zou hebben: de Japanse Pharmacopoeia en GMP-regulaties zijn eindelijk online te vinden op de site van de PMDA (Pharmaceuticals and
Nieuwe Guidance on Validation of Analytical Methods FDA publiceerde een nieuwe Guidance on Validation of Analytical Methods. Deze vervangt de vorige, wat na 14 jaar
FDA readiness Naar aanleiding van een inspectie door de gevreesde FDA, weerklinkt meermaals de term FDA readiness. Simpel gezegd komt het hierop neer: je kwaliteitssystemen
Meer inspecties wereldwijd Heuglijk nieuws, want na heel wat besparingen vorig jaar heeft de FDA nu een nieuw, uitgebreider budget. Daarvan willen ze heel de
Active Substance Master File Velen kennen ongetwijfeld de DMF, oftewel Drug Master File, een document waarin heel wat info rond het medicijn wordt meegedeeld met
Nieuw Chapter 2 Personnel EMA heeft de laatste maanden niet stilgezeten wat betreft hun algemene GMP-wetgeving. Sinds februari is het nieuwe Chapter 2 Personnel in
Wanneer een bepaalde GMP facility na FDA-inspecties non-compliance issues blijkt te hebben, krijgt die de nodige opmerkingen en aanbevelingen in een zogenoemde Form 483 of
UDI is a new system that assigns a unique barcode to each individual medical device. It will become mandatory when MDR and IVDR enter into force, so as a manufacturer, you need to make sure you’re UDI-ready in time.
During the QbD Corona World Games, our online international team building event, thirteen randomly selected teams defended their honor.
A short introduction and overview of the requirements In 2017, the European Commission released the new Medical Device Regulation (MDR) that will replace the Medical
One of our previous blogposts discussed innovations in the medical technology field and how these can fulfill unmet patients’ and physicians’ needs by leveraging the
Do you want to distinguish starting materials used for ATMPs from those used for transplants or transfusions? This distinction is made based on how the
Recently, we announced that Quality by Design and TRIUM Clinical Consulting have joined forces to create an end-to-end offering for the lifecycle of medical products
Among the Advanced Therapy Medicinal Products (ATMPs), in the immunotherapy market, nowadays two acronyms catch the eye: CAR-T and TCR-T. The two techniques are based
It’s obvious that product quality and patient safety are a top priority in the pharmaceutical industry. The quality by design methodology is used to build