Current Edition

Transport Risk Assessment and Verification – from Theory to Practice

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. Annegret Blum at PharmaLex explains that, while the respective requirements seem well implemented for storage facilities in the pharmaceutical industry and the supply chain, observations in audits and inspections, as well as frequent questions concerning the implementation of transport requirements, demonstrate that consultancy on this topic is highly valued.