Transport Validation versus Transport Verification - Aide Memoire "Inspection of the Suitability of Transport Processes"

Transportation in the pharmaceutical environment is more than just moving something from A to B. Pharmaceutical products must be transported safely and without compromising their quality. Documented proof evidence is required. What do the authorities require in this regard?

The original version of the German Drug and Drug Substance Act (AMWHV) from 2006 already contained the requirement to prove the suitability of transports with a potential impact on product quality. This requirement was regularly translated into the implementation of corresponding validations. 

With the revision of Annex 15 in March 2015, this topic was taken up under the term "verification" of transports. Experts were unanimous: this term is to be welcomed, but its meaning and implementation in practice leaves room for interpretation.

The Aide Memoire "Inspection of the suitability of transport processes" of August 2023 now sets out the view of the German authorities.

But what insights does the document published by the German ZLG provide? What does it mean in practice?
The new technical article from gempex is dedicated to this topic:
Tim Ohlrich, pharmind 05-2024: "Transport validation versus transport verification".

The author provides an overview of the elaboration on the quality assurance of transports, clarifies the meaning, scope and definitions of the Aide Memoire and gives reference to previous practice. Transport verification and transport validation are critically scrutinized and the possibility of how verification can be usefully supplemented by partial validation with regard to flexibility, costs and the scope of monitoring transport processes is discussed.

The article is available for download at

For a professional exchange or further information, please contact Tim Ohlrich, Manager GMP Compliance Projects at gempex GmbH,