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Factory Acceptance Testing: not a simple business

19/1/2016 - Kin Chun Cheung, Project Manager Pharmaceutical Engineering at Quality by Design

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…

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HistoGeneX chooses Quality by Design for quality assurance

15/12/2015 - Yves Dène, Lead Consultant CSV at Quality by Design

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…

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

5/12/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

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…

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Pharmaceutical industry: compliancy doesn’t always equals quality

1/12/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

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…

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QbD in the United States: work hard, play hard

20/10/2015 - Elly De Bruyn, HR Manager at Quality by Design

‘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…

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Medical device legislation: how to keep up to date

13/10/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

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…

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EudraLex Vol 4: New Annex 15: Qualification

13/10/2015 - Bart Van Acker, Founder/Managing Director at Quality by Design

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…

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Vaccinating: a new key role for pharmacists?

7/10/2015 - Bart Van Acker, Founder/Managing Director at Quality by Design

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…

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QbD’s foot in the door

25/9/2015 - Bart Van Acker, Founder/Managing Director at Quality by Design

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?…

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High quality, low risks: how to optimize pharmaceutical and medical quality control management

11/9/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

Last March, the European Union published updated guidelines in the Eudralex – Volume 4: Good manufacturing practice (GMP) Guidelines. The chapters on Premise and Equipment,…

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Draft paper on new EMA guidance for importers of medicinal products

14/7/2015 - Bart Van Acker, Founder/Managing Director at Quality by Design

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…

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General GMP

14/7/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

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…

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Good Distribution Practices (GDP)

8/4/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

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…

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Combination products – deel 3

19/3/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

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…

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Combination products – deel 2

26/2/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

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…

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Een kwaliteitsvolle Valentijne

14/2/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

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…

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Combination products

4/2/2015 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

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…

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Medical devices in de US

17/11/2014 - John Nuyens, Pharmaceutical Project engineer at Quality by Design

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…

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