Simone Ferrante

In Europe, companies with a wholesale distribution authorisation, the management must appoint a responsible person who is responsible for the introduction and implementation of a quality management system and compliance with the GDP rules.

Receipt of medicinal products: When materials or products are delivered, their quality is assessed. Therefore, this work step should be carried out by experienced and particularly reliable employees.

GMP or GDP – Which applies for importation? Although the import of medicinal products is an act related to distribution and logistics, this activity is considered GMP relevant in the EU and is therefore subject to GMP requirements.

Assessment of GxP relevance

Every upcoming change must be checked for GxP-relevance by the responsible person for GDP.

You might be thinking: “It's clear – GMP applies to manufacturing and GDP to distribution!” But is this distinction always so unambiguous? Unfortunately not, says Simone Ferrante, author of the knowledge portal GMP:KnowHow Pharma Logistics (GDP). From her many years of professional experience, she knows a number of topics where the legal situation is insufficiently harmonized and therefore unclear.
Find out more about the interfaces between GMP and GDP and test your knowledge in today's feature!