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21 Mar 2022

Mitigating supply risk: Having feet on the ground during COVID-19

Having personnel on the ground may be central to mitigating supply chain risks, even as the world embraces the remote approach. 

Auditing remains a challenge for pharmaceutical companies, with pandemic-induced restrictions limiting their ability to conduct in-person inspections of contract manufacturing organisations (CMOs).   

Health authorities and CMOs have been forced to adopt new processes for conducting audits, with many utilising a remote-first approach to avoid delays in the approval of new products or post-approval changes.  

While remote audits are proving useful in bridging the gap caused by travel restrictions and social distancing measures, they do not come without their challenges and are not considered a replacement for inspections by the US Food and Drug Administration (FDA).   

Issues related to technological availability and clear communication are compounded by the fact that not all pharmaceutical companies have local organisations in countries where their CMOs are based. Having qualified “feet on the ground” can prove advantageous in managing the audit process and ensuring compliance.   

Nanjing Chemphar, a provider of pharmaceutical-related products and consulting services, has been assisting manufacturers with improving Good Manufacturing Practices (GMP) and Environmental Health & Safety (EHS) qualifications and helping them to pass US FDA, EU EDQM and Japan PMDA auditing.   

Their QA Department works with local manufacturers to improve their GMP, with the goal of increasing customer satisfaction and creating sustainable sourcing.   

Founded in 1975, Nanjing Chemphar handles the full supply chain as required by their customers around the world; from finding the most suitable factory, negotiating prices, final product quality assurance, insurance, shipping and delivery.   

René Zoetmulder, a Partner at 4SCENERGY, described utilising Nanjing Chemphar’s services while leading the procurement organisation of a Netherlands-based pharmaceutical company during the COVID-19 pandemic.   

Faced with sourcing risks compounded by regulatory constraints and obligations, he initiated a supply risk reduction program with a focus on security of supply, GMP and EHS.  

He said: “During the first COVID-wave this company was, due to the professional team of Nanjing Chemphar, able to more than double the output of a drug that is used during ventilation of patients in IC, not having any production disruptions caused by the unavailability of the materials.”   

Nanjing Chemphar recently started a partnership with 4SCENERGY, with the goal of enhancing support and reducing supply risks for overseas customers. 


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