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Qualification of Pharmaceutical Shipping Systems in Seven Steps



In the pharmaceutical supply chain, a qualified shipping system (QSS) is required in order to secure and maintain quality, efficacy, and safety of products during transportation. A QSS can be defined as a transport process that consists of a qualified vehicle and/or equipment (e.g., active and/or passive transport system) with payload that is moved from origin to destination (shipping lane) via planned transit nodes using qualified transport modes (e.g., road, air, ocean, and/or rail) and qualified logistics service providers (LSPs) under known seasonal conditions, time constraints, and risks (1). As qualification of shipping systems is a growing regulatory requirement for shippers of temperaturesensitive pharmaceutical products, supply chain disruptions (e.g., strikes, weather conditions, delays, pandemics, etc.) should be adequately managed to ensure full supply on time to prevent market shortages. The industry requires a clear understanding of the qualification requirements and an aligned approach towards authority’s expectations.

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About the authors

Dr Erik J van Asselt has been working for more than 20 years in the pharma industry with strong experiences in temperaturecontrolled distribution, data integrity, quality risk management, lean six sigma, packaging, and stability testing. Together with PDA and PCCIG members, he has organised conferences and training courses, and he has written many PDA technical reports and articles about temperature-controlled supply chain management. Erik is a professional with a PhD in Protein Crystallography from University of Groningen, The Netherlands.

Dr Zvonimir Majic is an industry expert specialised in QRM systems for healthcare logistics and airfreight industry. With 20 years in quality assurance in the aviation industry and a decade in the pharma industry, he worked on QRM systems development and implementation, published over 20 international scientific articles in the field of process design, quality, and risk management for time and temperature-critical products and represented industry through PDA, IATA, and ECA interest groups. He is an EOQ certified Quality, Risk, and Process Design Manager. In his professional career he held over 50 international seminars on QRM systems for the healthcare and air freight industries.

Dr Rafik H Bishara has become one of the most respected figures in the pharma supply chain distribution sector, following a distinguished 35-year career with Eli Lilly and Company as Director, Quality Knowledge Management, and Technical Support. He is the former (1999-2019) Chair of the Pharmaceutical Cold Chain Interest Group, US branch, within the PDA. Rafik is currently on the pharmacy advisory council Utilization Review Accreditation Commission. He was a temporary advisor to WHO 2007-2018 and acted as mentor and training advisor to the WHO-PDA Pharmaceutical Cold Chain Management on Wheels.

Eric Stener has 17 years of experience in manufacturing, 10 years of which as head of filling and lyophilised injectable products. He has worked in Sanofi and Sanofi Pasteur Quality Supply Chain Division as a Quality Expert on transportation and storage of pharma products and supply of materials for vaccines since 2006. Eric has also been a PDA member since 2017 and is a member of the PDA Europe Pharmaceutical Cold Chain Interest Group. He participates in numerous international seminars in China, India, and Europe as a speaker on GDP for pharma products and means of transport such as qualification and monitoring. He has also published and co-authored articles about GDP for pharma products.
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