EMA Concept Paper on Storage Conditions during Transport

The European Medicines Agency (EMA) has published a concept paper on storage conditions during transport (EMA/INS/GMP/638479/2010).

The goal is to create new Good Distribution Practice (GDP) and GMP guidance and may lead to the need to revise the guideline on declaration of storage conditions (CPMP/QWP/609/96/Rev2). This current guidance was written in 1996 and revised in 2003, during this time significant changes continued to occur in the globalisation of manufacture with a consequent increase in the complexity and vulnerability in the supply chain, leading to a lack of clear guidance on the regulatory expectations for ensuring that medicinal products and APIs are not damaged during transportation.

What might be the consequences of such a new guidance?

  • Compliance at all stages of manufacture and distribution becomes more important as the number of transport stages increase, including transport (i.e. import) into the EU.
  • As many sites of manufacture are located in tropical zones and/or where transport infrastructure may be difficult, the challenges arising from transport between such sites and from these sites to the EU must be considered.
  • The risk of freezing during transport and the effects on the products should be considered
  • Principles of quality risk management are expected to be applied on a product by product basis at each stage of manufacture and transport.

Comments should be provided to ADM-GMDP@ema.europa.eu until 28 February 2011.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA) 

P.S. During the ECA Course on GMP in Storage, Transportation and Cold Chain on 03 - 04 March 2011 in Prague, Czech Republic, well experienced speakers will share their expert knowledge about all relevant aspects regarding the actual GMP requirements and current developments in storage, transportation and Cold Chain Management.

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