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Markus Maier

Markus Maier is a Product Manager for sterilizers at Belimed Life Science, based in Mühldorf am Inn, Germany.

Sep 30, 2026

14:28
Like, why isn't everybody doing it? But you don't see consistent application across the industry, right? So the thing is,
14:35
I would say a lot of companies are already following this guidance and these regulations because it's a big part of the contamination control, as you already mentioned.
14:48
the risk-based approach, which is more and more the focus in the industry, right? So basically, what the Annex 1 is describing is not really new for the industry, but it is written down in a compact paper and describes all the important things which are necessary to follow up to be able to produce safe drugs.
15:13
And therefore, the Annex 1 or the Annex term NX1 is easy to explain in a certain some words it's Just a regulation or an overview how to produce drugs for safe drugs for the patients.
15:29
That's a
16:05
it's
16:05
much, much more behind this.
16:08
As you said, the facility layout is one topic.

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