EMA: Regulatory and procedural guideline: Concept paper on Storage Conditions during Transport, draft.
23.11.2010
The globalisation of the manufacture of human and veterinary medicinal products has brought both
benefits and a wide range of challenges. This paper is concerned with challenges related to the
maintenance of appropriate transit conditions during transport as products move through all stages of
the manufacturing and wholesale distribution system from active substance through the wholesale
distribution system to ensure that patients and animals receive safe and efficacious medicinal
products. The current guidance (CPMP/QWP/609/96/Rev2) 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.
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