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Artificial intelligence (AI) in consulting

How artificial intelligence is revolutionizing management consulting: Insights into a future where consultants and AI, go hand in hand In the rapidly evolving business world, companies face the challenge of keeping up with the latest technologies…
Lieferantenqualifizierung
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Supplier qualification for pharmaceutical manufacturers

Blog post: Field report by an EI consultant from a supplier qualification project for pharmaceutical manufacturers In the period from 2019 to 2022, I was involved in a project for the supplier qualification of drug manufacturers and active…
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GMP AND DIGITALIZATION: SOME BASIC THOUGHTS

It is almost 8.00 am, we are standing on front of a building which houses an officially GMP-accredited contract laboratory service. Our task for today: carry out a full blown GMP-audit on the contract lab. On the inside I am a bit excited,…

Shaping the future: AI as the key to progressive corporate governance

Artificial intelligence (AI) is more than just a buzzword from the world of science fiction and robotics - it is a technology that is deeply integrated into our everyday lives. As a dynamic and progressive field, AI aims to develop systems that are capable of performing tasks previously reserved for the human mind.

Annex 1 – Revolution in GMP heaven?

a document that is awaited with more excitement than ever before in the history of GMP regulations. One reason for this is that Annex 1 has now been available as a draft for more than 4 years and its publication has been repeatedly delayed for various reasons. According to current information, the publication is now scheduled for September 2022.

EUDRALEX Vol. 4 Part IV: One for all?

Advanced therapy medicinal products (ATMPs) are at the forefront of regulatory developments, including good manufacturing practice requirements. A still very young ATMP GMP guide is going down paths that have not yet existed in the GMP universe.

The new ANNEX 1 02/2020

One of the significant revisions in the draft of the new Annex 1 is the change in the limitation of the bacterial count in cleanroom class "A". Whereas the previous requirement was that a maximum value of "< 1" was permitted in the core zone of aseptic production, the limit is now set to "no growth", i.e. "0" CFU/sampling.

GMP reagent management: Many unspoken rules?

So inconspicuous and yet so important, especially from today's perspective: Section 6.19 of Chapter 6 of the EU GMP guidelines once again significantly increased the effort required to carry out analytical tests. 6.19 Special attention should…
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The GMP Management Review

The GMP Management Review: A highly underestimated instrument of quality assurance The GMP Management Review: A highly underestimated instrument of quality assurance The management review is not a new instrument in the GMP quality system;…

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