Europe – EC Offers Help to Wholesalers on GDP Inspections

To help pharmaceutical wholesalers comply with good distribution practice (GDP) inspections, the European Commission on Tuesday released a new aide memoire.

The six-page document comes in the form of general questions, as well as more specific ones related to a wholesaler’s quality system, verification of a medicine’s safety features, suspected falsified medicinal products and decommissioning of unique identifiers (UIs), among others. The document also offers references to guidelines and articles within Regulation 2016/161.

Questions range from “Is the wholesaler a ‘designated wholesaler’? For what companies and products? If yes, show me the written contract, where the wholesaler is named as ‘designated wholesaler’ by the MAH [marketing authorization holder]” to “How is the integrity of an entire aggregated shipper/pallet verified?”…