Login / Signup

Assessments of the quality systems of pharmaceutical distributors: a remote approach to be applied in times of COVID-19 and beyond.

Anthony BourasseauLaurine LavergneRaffaella Ravinetto
Published in: Journal of pharmaceutical policy and practice (2021)
Our findings 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 pre-screening candidates for on-site assessments, and for targeted follow-up of on-site assessment.
Keyphrases