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Post-Market Surveillance of Medical Devices

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

Medical devices: innovations versus regulations

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

QbD pyramid corporate levels

Automation Pyramid – FAQ

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

How to start with computer system validation?

What to focus on when validating a computer system? (2)

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.

technology transfer by quality by design

Three important trends in technology transfers

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?

How to start with computer system validation?

What to focus on when validating a computer system

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.

Predict seizures with Apple Watch

The use of wearables in diagnosing and preventing of diseases

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?

technology transfer by quality by design

Tech transfers: what are the drivers of complexity?

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.

technology transfer by quality by design

These factors can make or break your technology transfer

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

QbD: a quality-focused process development roadmap for ATMPs

Anything you need to know about ATMPs: FAQ

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

Computer Systems: is Assurance the new Validation?

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.

Market release of vaccines: European Union versus the United States of America

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.

Watch out for the Pink Army

QbD is known for its team spirit and sporty character. This isn’t only the case at the office, but also outside of work!

How Europe is fighting falsified medicine

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

Sweating out the Monday blues

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

A critical look at the new Annex 1 draft of the EU GMP

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

Challenges & opportunities in the Medical Devices landscape

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.

Ensuring quality management in other industries? Check!

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

Ensuring full data integrity, without any exceptions

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

Updating Good Clinical Practice E6(R2)

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

MHPRA in UK releases GxP Data Integrity guidelines

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

New Annex 1 draft of the EU GMP

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

What are Good Distribution Practices?

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

New steps by FDA & EU to eliminate double drug inspections

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

QbD competence centres: 4 levers to boost expertise

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

Digitalizing healthcare step by step

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

Preparing for growing challenges in pharmaceutical serialization

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

Echoes from a QbD training: the power of Lean

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

From CCKL to ISO 15189 – what you should know

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

HistoGeneX chooses Quality by Design for quality assurance

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

Eudralex Vol 4: New annex 15: Qualification (PART 2)

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

QbD in the United States: work hard, play hard

‘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

Medical device legislation: how to keep up to date

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

EudraLex Vol 4: New Annex 15: Qualification

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

QbD’s foot in the door

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?

General GMP

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

Harmonised Guideline For Elemental Impurities

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

Good Distribution Practices (GDP)

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

Combination products – deel 3

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

Combination products – deel 2

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

Een kwaliteitsvolle Valentijne

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

Combination products

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

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

Nieuw bij EMA (3)

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

Nieuw bij EMA (2)

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

Wat is ANDA?

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

Nieuw bij EMA (1)

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

Japanse Pharmacopoeia en GMP-regulaties

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

Nieuw bij FDA (3)

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

Nieuw bij FDA (2)

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

Nieuw bij FDA (1)

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

Nieuw in de GMP-wetgeving van EMA (2)

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 in de GMP-wetgeving van EMA (1)

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

EMA publiceert GMP black list

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

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Post-Market Surveillance of Medical Devices

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

Medical devices: innovations versus regulations

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