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Assessments of the quality systems of pharmaceutical distributors: a remote approach to be applied in times of COVID-19 and beyond
Article Number: SIS536812AI150123
15th January, 2023
Author(s):
Anthony Bourasseau, Laurine Lavergne & Raffaella Ravinetto
Abstract:
Background: Adequate quality systems throughout pharmaceutical supply chains are crucial to protect individuals
and communities from substandard and falsifed medical products. Thus, pharmaceutical distributors are regularly
assessed by qualifed experts. Since the COVID-19 pandemic has forced a suspension of normal activities, remote
assessments via videoconferencing may represent a temporary alternative to on-site audits. We exploratorily evaluated the feasibility of remote assessments of pharmaceutical distributors, located in a low- or middle-income country
hard-to reach during the COVID-19 pandemic.
Methods: We conducted pilot remote assessments of four conveniently selected distributors. The expert was
remotely connected via videoconference, and supported by an in-country assessment facilitator (ICAF), who had
received ad hoc training and was present at the assessed facility. First, the remote expert assessed the quality assurance (QA) activities and rated their compliance with the standards of the World Health Organization Good Storage &
Distribution Practices (GSDP), as per routine practice. Second, s/he assessed the completeness, clarity and accuracy of
data collected remotely, frst per distributor, and then in aggregated form.
Results: Data completeness was assessed by the expert as excellent, while clarity and accuracy were good. Overall
data quality (a combination of completeness, clarity and accuracy) was good, with no major diferences across QA
activities, nor across distributors. Contextual limitations included poor internet connection, language barriers, and
distributors’ lack of familiarity with QA terminology.
Conclusions: Our fndings are exploratory and cannot be extrapolated to other contexts, nor to other types of audits.
Nonetheless, this pilot experience suggests that a well-planned remote assessment of pharmaceutical distributors,
conducted with the support of a well-trained onsite ICAF, can provide data of acceptable quality, allowing to assess
GSDP-compliance and to make temporary decisions about licensing or purchasing. Purchasers and policy makers
should read the results of remote assessments in light of their intrinsic limitations. At the moment, onsite assessments
remain the gold standards, but this could change in the longer term, with improved information technology and in
light of the need to avoid unnecessary travels. Furthermore, remote assessments could be considered for routine prescreening candidates for on-site assessments, and for targeted follow-up of on-site assessment.