as of 2019 - 03 - 18

21.F Chemical active substances

21.F Chemical active substances
Here you will find answers to the following questions:

What are chemical active substances?

How do chemical active substances differ from other active substances such as biotechnological or herbal active substances?

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

What GMP requirements are in effect for chemical active substances in addition to general GMP rules?

What particular risks have to be considered?

What GMP deficiencies are often cited in audits?

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