EU Commission publishes new draft guideline on Good Distribution Practice

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EU Commission publishes new draft guideline on Good Distribution Practice for review by December 31, 2011.

The EU has published for comment a much more stringent set of guidelines for Good Distribution Practices. These guidelines reflect current EU and FDA thinking on security of the global supply chain, more involved vendor management, computerized systems and qualification/validation, documentation, risk management, and transportation. The guidelines are the outcome of the requirements of the new EU Directive on Falsified Medicines.

Read the guidelines here.