Whitepaper: Transport risk assessment and verification - from theory to practice

Transport is nowadays jointly acknowledged as “mobile storage”. However, compared to the storage in warehouses, there are much more external factors that may affect product quality during transport.

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Legal and regulatory requirements, including GMP and GDP guidelines, require consistently that medicinal products shall be stored and transported in a way that the product delivered maintain their quality and integrity and remain within the legal supply chain during storage and/or transportation. Storage and transport need to be described in the Pharmaceutical Quality System and the principles of quality risk management shall be used for designing and managing these activities.

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