[HTML][HTML] The requirements for manufacturing highly active or sensitising drugs comparing Good Manufacturing Practices

P Fabio, C Alessandro, S Stefania… - Acta Bio Medica …, 2019 - ncbi.nlm.nih.gov
Background: To date there exist no internationally recognised Good Manufacturing Practices
(GMP) that clearly outline universally accepted standards for manufacturing highly active or …

[PDF][PDF] Good manufacturing practice for medicinal products in Bulgaria: an analysis of regulatory inspection findings

AH Stoimenova, BJ Kirilov, SR Gueorguiev… - Folia medica, 2020 - foliamedica.bg
Background: The manufacture of medicinal products for human use in the European
Economic Area is governed by European Directives and Regulations stipulating the relevant …

[PDF][PDF] Good manufacturing practice: the role of local manufacturers and competent authorities

S Tomić, A Sučić, A Martinac - Archives of Industrial Hygiene and …, 2010 - sciendo.com
In every country, a manufacturer of medicinal products for either human or veterinary use is
required to operate in compliance with local legislation. In all EU Member States, legislation …

Good manufacturing practices (GMP) for medicinal products

JB Karmacharya - Promising Pharmaceuticals, 2014 - books.google.com
The term GMP was introduced to regulate manufacturing and packaging operations in the
pharmaceutical company. Until the mid-1960s, operating procedures for the manufacture of …

Analysis of the pharmaceuticals market and its technological development in Turkey

A Kisa - International journal of technology assessment in …, 2006 - cambridge.org
Objectives: The objectives of this study were to analyze the current structure of the Turkish
pharmaceuticals market to explain the latest developments and to offer some insight into the …

The role of scientific research in the field of medicines and the development of the pharmaceutical industry

G Victor, S Ecaterina, C Ianos - The Moldovan Medical Journal, 2018 - cyberleninka.ru
Background: Approximately 91% of drugs are imported, some of which are quite expensive
and unaffordable for the majority of the population. The process of drug development, ie the …

Pharmaceutical industry and its influence on the state of healthcare in Poland, in view of the local innovative potential

W Kuźmierkiewicz, J Rachoń… - Polish Technical …, 2019 - yadda.icm.edu.pl
Availability of medicinal products is a crucial issue of any healthcare system. Pharmaceutical
industry, which is a global conglomerate of profit-driven private enterprises, needs much …

[PDF][PDF] Study on the range of drugs authorized in Romania–a determinant element for the accessibility and availability of drugs

AE Taerel, A Turcu-Stiolica - Farmacia, 2009 - researchgate.net
As a fact of drugs availability of the drugs in the pharmaceutical assistance of the population,
the range of pharmaceutical products authorized to be used in therapeutics represents the …

Impact of the Council of Europe Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of …

HPA Scheepers, VN Handlos, S Walser… - European Journal of …, 2017 - ejhp.bmj.com
Introduction and objective The regulation of pharmacy preparations, especially for standards
for quality assurance and safety, is not harmonised across Europe and falls under the …

Product quality, quality control and validation

R Lange, T Schnor - … Pharmaceutics: An International Guideline for the …, 2023 - Springer
The quality of pharmaceutical preparations is the result of the planning and implementation
of the manufacturing process. The Good Manufacturing Practice (GMP) principles and …