Understanding the environment through which a sensitive pharmaceutical/ life science product must travel is essential for any successful supply chain. It provides the solid foundation for design and choice of packaging that ensures the maintenance of the required product temperature during external distribution and satisfies a cornerstone paragraph of the EU GDP guidance document EU343: ‘Risk assessment of delivery routes should be used to determine where temperature controls are required.’
Any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings, which could affect the integrity of the product. There must be a written contract between the contract giver and the contract acceptor, which clearly establishes the duties of each party.1
To discover more about a key way forward in improving and maintaining temperature-sensitive product distribution standards, view the full white paper here.
1EU GDP Guidance EU343/01