EMA publishes concept paper on pharmaceutical cold storage conditions during transport

The European Medicines Agency (EMA) has published a concept paper on storage conditions during transport. 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.

Over the past few years, 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 or compromised during transportation.

Without key consideration for these guidelines, risk of freezing during transport increases and the effects on the products can lead to quality compromise and ultimately loss of profits.

IQPC's Cold Chain South Africa 2011 will provide practical knowledge on key operations within cold chain logistics and supply chain. Held in Johannesburg South Africa, from the 28 - 31 March 2011, the event will bring together original and generic Pharmaceutical manufacturers, Biotechnology firms as well as Government and Regulators to share best-practise in cold chain management.

This is your opportunity to exchange best-practices and practical solutions that can be implemented to improve service delivery and future planning.