EMA Concept Paper: Storage conditions during transport

The European Medicines Agency (EMA) published a concept paper on storage conditions during the transport (EMA/INS/GMP/638479/2010)  as a response to increased concerns on the security and integrity of the whole supply chain of pharmaceutical products. As stated in the document “the paper is concerned with challenges related to the maintenance of appropriate transport conditions during transport as products move through all stages of the manufacturing and wholesale distribution system."

The objective of the proposal is to create new Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) guidance and may lead to the need to revise the current “Guideline on Declaration of Storage Conditions” (CPMP/QWP/609/96/Rev2). The current guidance was written in 1996 and revised in 2003, but during this period important changes occurred that increased not only the complexity of the supply chain but also its vulnerability.

So what may arise from this consultation process?

  • Similar levels of storage controls should exist in the transport (considered as a form of mobile storage). Compliance at all stages of manufacture and distribution has now become more important than ever before.
  • Increased control in the length of time and climatic effects at different stages. Many sites of manufacture are located in totally different climates than the sites in the European Union. The risk of extreme temperature variations and freezing during transport and its effect on the products must 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. Set of general rules applicable to transport conditions to reduce complexity and risk of error.
  • The period for submitting comments finished on February 28th and it is expected that a first draft text will be released in June 2011 with a 3 month consultation period.

IEA Life Sciences Ireland can help you to start minimizing these risks now. Our Good Distribution Practice (GDP) Training (including GDP Driver Training), will teach you and give you the knowledge to help you overcome transport and distribution challenges that the pharmaceutical industry is currently facing.

Check further information in the EMA web site.
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