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How to Prepare a GDP Inspection: Lessons Learned

Good distribution practice (GDP) inspections are expanding their scope to cover a wider area of involved stakeholders responsible for delivering medicinal products on time and in good order. GDP processes and standard requirements for storage premises, procedures, as well as employee and subject matter expertise training are complemented with computer systems, data integrity, and supply chain (SC) traceability and visibility. These topics require pharmaceutical manufacturers to extend their understanding, knowledge, and visibility of the SC and logistics services to a next level thus ensuring an up-to-date GDP compliance.

Embracing GDP

Developing and living a GDP culture in all aspects of the SC comes as a complex and multidisciplinary task for any wholesale distributor. Although the GDP of medicinal products for human use 2013/C 343/01, issued in 2013 by the European Commission, is a guideline document and not a law, all member states, and some others, have embraced the principles thereof and embedded them in their national legislation related to the holding and distribution of medicinal products (1-3). Areas of GDP on which inspections are conducted today are no longer reserved for standard quality and risk management systems (QRMS), but are reaching out to the SC as a whole from manufacturing to patient. In such circumstances, product storage along with distribution traceability and visibility are no longer only on a level of temperature integrity during distribution, but also cover a much wider area of the SC, including all stakeholders' holding and handling of medicinal products, and relevant documentation.

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Dr Zvonimir Majic is an industry expert who specialises 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 SC 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.
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Dr Zvonimir Majic
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Dr Rafik H Bishara
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