Pharmail

New GDP guidelines for APIs

This past March, the EU commission published new guidelines on the principles of Good Distribution Practice (GDP) of active substances for medicinal products for human use. These guidelines are intended to strengthen transparency and provide stand-alone guidance on GDP for importers and distributors of active substances.

It is now mandatory for pharmaceutical manufacturers to ensure that all active substances are procured from registered manufacturers, importers and distributors. All active substance suppliers are required to check that their customers are legitimately allowed to receive active pharmaceutical ingredients. These guidelines will take effect September 21, 2015.

Merck is working on the implementation of the customer legitimacy check. In order to keep efforts for our customers as low as possible, we are cross-checking the Manufacturing and Importation Authorization (MIA) status in the Eudra GMDP database. And to ensure our own compliance of the guidelines, all Merck API-manufacturing and distribution sites in the EU have been registered according to Article 52a of Directive 2001/83/EC.

In This Same Issue

• Application of QbD Principles to Ultrafiltration Operations in Bioprocessing
• IEX Chromatography: Optimization strategies for higher purity
• Introducing Mobius® 2000 L Single-use Bioreactor
• Introducing Provantage® Clone Generation Services

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