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Cleaning Validation Glossary

Governance

Oversight and control

The governing bodies are the Federal Drug Agency (FDA), The International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH), European Medicines Agency (EMA), United States Pharmocopiea (USP), among others depending on both the manufacturer's country and those which the manufacturer exports to. There may be considerable overlap between the governance of these agencies but, there may be slight differences which should be understood.

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