Good Manufacturing Practice for Medicinal Products in Bulgaria: an Analysis of Regulatory Inspection Findings

Background: The manufacture of medicinal products for human use in the European Economic Area is governed by European Directives and Regulations stipulating the relevant principles and guidelines of Good Manufacturing Practice, describing the minimum standard to be fulfilled in the production proces...

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Vydáno v:	Folia Medica Ročník 62; číslo 1; s. 165 - 171
Hlavní autoři:	Stoimenova, Assena H., Kirilov, Bogdan J., Gueorguiev, Stanislav R., Petkova-Gueorguieva, Elina S., Ognianov, Sava G.
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	Bulgaria MEDICAL UNIVERSITY- PLOVDIV 31.03.2020 Pensoft Publishers
Témata:	Bulgaria Competent authority Compliance Drug Compounding - standards Drug Industry - standards Drug Recalls Good Manufactu Good Manufacturing Practice Guideline Adherence - statistics & numerical data Guidelines as Topic human medicine Humans Inspections Manufacturers Manufacturing Marketing medicinal products Quality Control Regulatory agencies Retrospective Studies Bulgaria medicinal products deficiencies Good Manufacturing Practice compliance human medicine
ISSN:	0204-8043, 1314-2143, 1314-2143
On-line přístup:	Získat plný text
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