Your EU GDP Journey
The regulations for the transportation of pharmaceutical products are tightening all the time. The requirement to maintain label claim during transport as well as storage effectively means that all products require some form of temperature control, protection, risk mitigation or risk assessment.
Different companies have taken different approaches, highlighting the ambiguity/flexibility inherent in the guidelines. Some have interpreted them to mean that all products require temperature control and have implemented this across their international supply lines. Others have taken this paragraph from section 9.2 and used it alongside stability data to justify their current (pre new GDP) practices “Risk assessment of delivery routes should be used to determine where temperature controls are required.” Some are even looking to change the “label claim” temperatures in their marketing authorisations to avoid making any logistics changes.
Regulators have come forward with differing interpretations of some sections, for example the UK’s MHRA advises that transport is an extension of storage and that a wholesaler dealer licence should be present for product remaining in situ beyond 36 hours; other EU authorities state different times with a common quote being 48 hours. This lack of a single definition does not help pharmaceutical manufacturers and logistics providers when trying to ensure their supply chains are GDP compliant.
So, 3 years on from publication of EU GDP, where should you be and in which direction should you be going?
Source: Cold Chain IQ
