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?”
Other questions ensure wholesalers can verify the authenticity of the UI and the integrity of the anti-tampering device (ATD). Inspectors may also seek information on medicines within a wholesaler premises that have a decommissioned UI, a UI that raised an alert or medicines with a broken ATD.
If a wholesaler outsources some of the logistics work, the aide memoire notes that inspectors may review the technical agreement/contract with respect to responsibilities related to the Falsified Medicines Directive.
Other questions to look out for include: “Under what circumstances is the reversal of the status of a decommissioned unique identifier to an active status permitted?” and “Does the wholesaler verify the UI of medicines returned by customers?”
AIDE MEMOIRE FOR GDP INSPECTION OF WHOLESALERS COMPLIANCE WITH COMMISSION DELEGATED REGULATION (EU) 2016/161 FOR SAFETY FEATURES