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

28.03.2022

Question of the Week

Although this is somewhat imprecisely defined in the EU GMP Guidelines Part II, the introduction of an important structural element into the structure of the active substance is now regarded by the majority of parties as the latest starting point for compliance with the GMP regulations, in accordance with the specification of ICH Q11.

[GMP Compliance Adviser, Chapter 20.F]

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