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