European Commission GMP Guidelines to Take Effect in March

Drugmakers in the EU have less than seven months to conduct risk assessments of all the excipients they use under good manufacturing practices guidelines imposed by the European Commission.

The guidelines — which must be met by March 21, 2016 — require marketing authorization holders to assess their entire supply chains to identify risks to the safety and stability of excipients from their source through to their incorporation in finished dosage forms.

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