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Scope of Regulation and GMP Requirements in Biotechnological Production

First part of the following article focuses on the regulatory framework for the production of biotechnological active pharmaceutical ingredients (APIs).
There are European Directives and national laws and regulations. Especially for regulatory issues of the biotechnological production one has to look at various documents of different origin. They all represent the current status of science of each subject discussed in these documents.
Typical examples of such regulatory papers in the field of biotechnology products are given.
The content of inspections and their regulatory basis are presented in the second part of this contribution. GMP requirements for biotech companies are discussed from the point of view of an in-spector of a German district authority responsible for granting manufacturing licences. However, usually such inspections are conducted by a team consisting of inspectors of the district authority and the state authority responsible for granting marketing licenses.
Besides the discussion about APIs pro-duced by fermentation or cell culture processes there are remarks on the new biotechnology area Tissue Engineering.