Quality management in pharmaceutical procurement: Most frequent non-conformities in pharmaceutical wholesalers in Bulgaria

Abstract

The goal of the study was to analyze the results of 31 quality audits of seven pharmaceutical wholesalers performed in 2002- 2012 and to discuss the most frequent non-conformities. The findings raised during the audits were systematized according their gradye{cyrillic}, nature of cause and consequences for the quality of the products and services provided. In total, 41 deficiencies were recorded: 26 (63.41 %) of them concerned the storage of pharmaceutical products, especially the cold-chain pharmaceuticals, and 10 concerned the documentation of different processes such as cleaning, trainings, transfer of responsibilities etc. We recommend that the Bulgarian Drug Agency prepare guidelines for distributors as other regulatory institutions in the EU have done, summarizing the best practices in pharmaceutical wholesaling as well as the deficiencies found during inspections. Such guidelines will benefit not only the wholesalers' quality management system, but also the society in general. © Biotechnol. & Biotechnol. Eq.