Good Manufacturing Practice for Medicinal Products in Bulgaria: an Analysis of Regulatory Inspection Findings.
Assena H StoimenovaBogdan J KirilovStanislav R GueorguievElina S Petkova-GueorguievaSava G OgnianovPublished in: Folia medica (2021)
Our analysis of Good Manufacturing Practice inspection findings in 2016 and 2017 showed that the Bulgarian Drug Agency demonstrated its ability to detect non-compliances and take necessary regulatory actions. Quality related issues constitute the main reasons for non-compliances with the requirements.