News about GMP/cGMP


EC: Aide-Mémoire on GDP Inspections of Wholesalers

On 18 November 2019, the European Commission published the "Aide-Mémoire for GDP inspection of wholesalers compliance with commission delegated regulation (EU) 2016/161 for safety features". As a checklist, the six-page document is intended to assist wholesalers in complying with the relevant GDP regulations on safety features.

 The Aide-Mémoire lists questions to be asked during an inspection as well as the documents that should be ready at hand during the inspection. The questions range from general information such as

  • How are the different requirements for the different products controlled/managed? Are the requirements built into to the product master data on the inventory/stock control system?
  • 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.

but also includes specific questions about the

  • quality system
  • data management
  • verification of security features
  • handling of returns or
  • handling of counterfeit products.

An additional column lists various references to corresponding text passages within suitable regulations. Click here to browse this helpful and well structured GDP document.

By the way: Here you will find the corresponding Aide-Mémoire for GMP inspections.


EC: Falsified Medicines