In order to take account of modern and globalized logistics, the EU-GDP guidelines consistently continue the high level of quality from production in accordance with GMP requirements in distribution. The "transport is mobile storage" approach makes it clear that pharmaceutical logistics has a direct influence on product quality and thus underlines the obligation of distributors and logistics service providers to use only qualified facilities and validated processes.
Storage and transportation must not adversely affect the quality of medicinal products and starting materials. Mix-ups must also be avoided. The requirements for this can be found in the Good Distribution Practice (GDP) of the WHO, in the EU GMP guidelines and in country-specific legal requirements (CFR, AMBO, AMWHW).
The first EU guideline on good distribution practice for medicinal products for human use was published at the beginning of March 2013. This guideline was revised in November 2013 and has been valid since then.
These requirements from all binding regulations are implemented through appropriate measures, including in
