Blog | QbD Group

Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring

Compressed air and other proces gases are used in a lot of different steps during pharmaceutical manufacturing. Some examples are the use of compressed air in direct contact with products to clean, aerate, or move them through the processes or the using process gases in fluid pumps that take products through the production and filling processes. Compressed gases, such as nitrogen or argon, can also be used for blanketing or to spray or coat a product. The risks associated with the use of these gases, depend on the amount and type of product contact and based on this risk assessment, a suitable monitoring plan should be in place.

Meet QbD Ambassador and Clinical Pharmacology & Pharmacometrics project lead Thomas Van Looy

At the QbD Group, we want to take into account the opinion of our employees. Therefore, our Board of Ambassadors was elected to represent the voice of all QbD’ers, within and outside of the group. Thomas Van Looy has been elected as one of our Ambassadors for 2022. Congratulations, Thomas! As an Ambassador, he loves to share his QbD Group experiences. Want to find out more about Thomas’ #QbDream job? Then don’t miss out on the interview below.

Meet QbD Ambassador and Validation Engineer Marijn Bollema

At the QbD Group, the opinion of our employees matters. Therefore, we formed a Board of Ambassadors to represent the voice of all QbD’ers, within and outside of the group. Marijn Bollema has been elected as one of our Ambassadors for 2022. Congrats! As an Ambassador, Marijn wants to show the world what it’s like to be a true QbD’er. Want to find out more about his #QbDream job? Make sure to read the interview below.

Data migration in CSV: definition, purpose, and best practices

Sometimes it is necessary to perform data migration in computer systems, applications, or software. Learn more about the goal, importance and risks here.

Meet QbD Ambassador and Device Compliance Specialist Catarina Cruz

At QbD, we value the opinion of our employees. Therefore, QbD’s Board of Ambassadors was formed to represent the voice of all QbD’ers, across the QbD Group and across all borders. Catarina Cruz has been elected as one of our Ambassadors for 2022. Congratulations! As an Ambassador, Catarina loves to share how she experiences working at QbD. Want to find out more about her #QbDream job? Make sure to read the interview below.

New GMP Annex 21 ‘Importation of Medicinal Products’ – Are you ready?

On August 21, 2022, the new GMP Annex 21 will enter into force. This Annex contains the GMP requirements for MIA holders when importing medicinal products from outside the EU/EEA. Learn more here.

Clinical Evaluation Report (CER): a must-have for all medical device classifications

To document the clinical evaluation of your device and its output, a Clinical Evaluation Report or CER has to be compiled. Learn more about this key document, its content, common gaps and hurdles.

How to use electronic signatures in regulated industries?

During the pandemic, electronic signatures gained tremendous importance for companies in the regulated sector. Learn more about electronic signatures, their use and safety here.

Clinical Evaluation Plan (CEP) roadmap for your clinical evaluation strategy

Clinical Evaluation Plan (CEP): roadmap of the clinical evaluation strategy

The Clinical Evaluation Plan, or CEP, is a crucial starting point and guide for the clinical evaluation of your medical device. Learn more about this key document and its requirements.

What is decommissioning in CSV?

In CSV, decommissioning is the retirement or controlled shutdown of an IT solution or computer system that is no longer needed. Learn more about this process here.

10Y Steven Vinkx at QbD: from Project Engineer to Head of PMO

Steven Vinkx has been working for QbD for 10 years now, and counting. Congratulations! Curious about his career and insights? Then be sure to read this interview!

Clinical evaluation for medical devices under MDR: a brief guide

Clinical evaluation of medical devices is critical to obtaining and maintaining marketing approval in the EU. Learn more about clinical evaluation here.

EDQM and the CEP of the future

A certificate of suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is considered to replace the relevant sections in the application for marketing authorization demonstrating the quality of substances for pharmaceutical use. The inclusion of a CEP in an MAA simplifies the review process for authorities and the submission procedures for industry. However, with the upcoming changes to the EU pharmaceutical legislation, the CEP procedure may be at risk. In this blog post, we outline the possible changes in the near future.

CAR-T cell therapy: highlighting the main components, manufacturing process, and prospects

CAR-T cell therapy uses genetically engineered T cells to destroy tumor cells. Learn more about the main components, manufacturing process and prospects of this promising immunotherapy.

10Y Dominiek Rossillion at QbD: from Quality Engineer to Business Development Manager

Dominiek Rossillion has been working for QbD for 10 years now, and counting! Our heartiest congratulations! Curious about Dominiek’s career and insights? Then be sure to read this interview!

What is EUDAMED and what new requirements should medical device companies take into account?

The new medical device regulations and the associated implementation of EUDAMED are intended to give the general public access to relevant information on medical devices, ensuring greater transparency. However, EUDAMED also brings new requirements for market participants throughout the life cycle of medical devices. Read more about them here!

GAMP categories for computerized systems: what are they and what are they for?

GAMP categories are very important to decide on the validation strategy of your computerized system. Learn more about all categories here.

10 questions for ‘10Y anniversary girl’ Katrien Janssens

10 years! That’s how long Katrien Janssens has been working at QbD now. Congratulations! Curious to know how Katrien has experienced the past decade at QbD? During a brief interview, we asked her 10 quick questions: one for each year she has worked with us!

3D Technologies Support World’s First Successful Double Hand and Face Transplant Materialise

3D printing enables patient-specific medical devices for a better quality of care

3D printing offers unrivaled flexibility and personalization in medical devices as illustrated by the case of Joe DiMeo’s face and hand transplant. Curious? Be sure to read on!

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

Regulatory Affairs plays a key role in the pharmaceutical industry: from drug development to commercialization. Learn more about the roles and functions that RA teams can provide in the lifecycle management of your pharmaceutical product.

Quality Control challenges in closed systems: implementing AI as an in-process control

Sampling, testing, and preserving your medicinal product in closed systems often present difficult Quality Control challenges. As part of the solution, various AI-based in-process controls can be used. Discover them here!

A Day in the Life of MD Specialist Steven

A Day in the Life of a QbD MD Specialist

Medical devices are one of QbD’s main areas of expertise. We support you from concept to launch in the full life cycle. Wondering what a day in the life of a QbD MD Specialist looks like? Let’s take a look behind the scenes!

Cell therapy as an ATMP: introduction, definition, and subtypes

Cell therapy includes various ATMPs to fight tumors or restore the physiological status of damaged tissue. Explore them here.

10 Questions for 10Y birthday boy Jeroen Verhoeven

10 Questions for ‘10Y anniversary boy’ Jeroen Verhoeven

If you know that QbD was founded 10 years ago, then it won’t come as a surprise to you that the 10Y anniversary of an employee is an EXTRA big deal to us. After QbD founder Bart (obviously), Jeroen Verhoeven is the very first employee to reach that landmark.

In order to give this news the attention it deserves, we fired 10 questions at Jeroen, one for each year he’s been with us!

QbD and TRIUM awarded with Baanbrekende Werkgever ‘22 certificate

On November 15, 2021, QbD and TRIUM received the Baanbrekende Werkgever ‘22 certificate for pioneering Belgian employers striving to put people at the center of their policies on hybrid work and mobility.

Dendritic cells: effective sentinels for immunotherapies

Dendritic cells play an important role in recently developed DC-based immunotherapies for the treatment of cancer, autoimmune diseases and the prevention of graft rejection. Read all about DC cells and their potential in this article.

Why NK cells are a major breakthrough in the field of ATMPs

NK cells, as part of our innate immune system, are very effective in killing different types of cells, including tumor cells. Because of these properties, they become very interesting as ATMPs for immunotherapy.

Curious about the potential of NK cells and NK-cell-based immunotherapy? Learn all about them here, including the benefits and challenges.

From IVDD to IVDR: avoid these pitfalls to get your CE marking in time

In the EU, the IVDR will replace the IVDD. The compliance deadline is approaching, so act now to obtain CE marking of your IVD medical device in time.

Medical device combination products: what regulations should you apply before marketing them in the EU?

Follow these steps before launching medical device combination products in the EU, including the application of MDR Article 117 and the EMA Directive.

IVDR classification of in-vitro diagnostic medical devices: a brief guide for manufacturers

Learn more about the new risk-based approach to in-vitro diagnostic device classification under IVDR 2017/746, replacing outdated directives.

MDR impact on MDSW: what has changed from MDD?

The introduction of MDR impacts CE-marked medical software (MDSW). Curious about the scope of this impact on your software? Read more below.

Medical Device Industry Trends: on wearables, AI, POC testing, IoT, and more

Curious about the latest medical device industry trends? Learn more on wearables, AI, POC testing, IoT, and more in this blog post!

QbD Academy welcomes 15 young graduates to jumpstart their careers in life sciences

The QbD Academy is a young graduates program that combines working, learning and intensive training. Last month, we welcomed 15 young graduates during our QbD Academy Week. Read all about it here!

Unraveling Artificial Intelligence in Medical Devices: what do we know so far?

Artificial Intelligence is the IT word in Medical Devices nowadays. Learn more on AI and its regulatory implications for manufacturers.

SaMD versus MDSW: what’s the difference between Software as a Medical Device and Medical Device SoftWare?

The terms SaMD (Software as a Medical Device) and MDSW (Medical Device SoftWare) are often used interchangeably within medical environments, but they are not. Learn the difference in meaning and regulatory scope here.

5 consequences of Brexit when selling medical devices in the UK

Brexit impacts the medical device markets of Scotland, England, Wales and Northern Ireland. Learn more on the consequences for manufacturers that place medical devices on the UK market here.

ATMPs: translating the expertise into a GMP process

ATMPs are a promising new type of medicine. Learn more about the challenges in translating the expertise into a GMP process.

QbD & TRIUM 10Y International Sports Challenge - 9

QbD & TRIUM’s 10Y International Sports Challenge: a mix of fun, exercise, and team spirit!

Sports have always been an essential part of QbD and TRIUM’s DNA. So – to celebrate both our 10-year anniversaries – we came up with an exciting event combining all of these values: our 10Y International Sports Challenge! Read all about it here.

Is your product a medical device? Well, that depends…

Whether your product is a medical device depends on the markets you want to enter and their regulations. Here’s an overview to guide you.

Why Medical Device Risk Management is as complex as it is crucial

Risk management, the key to medical device safety, involves much more than ticking the FMEA box. Jeroen Verhoeven, one of our specialists in the matter, explains why and guides you through the ISO14971 standard (application of risk management to medical devices).

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