as of 2019 - 07 - 01

21.G Biotechnological active substances

21.G Biotechnological active substances
Here you will find answers to the following questions:

What are biological and biotechnological active substances?

What types of biotechnological active substances are there?

What key terminology should you know about biotechnology?

From what stage of the biotechnological manufacturing process onwards do GMP regulations apply?

What particular risks have to be considered?

What GMP requirements are in effect for biotechnological active substances in addition to general GMP regulations?

Are there other GMP requirements relating to specific products?

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