Blog of our interpreters and translators for GMP and pharmaceutics
Our blog offers much more than just information about interpreting and translating between Russian, English, and German. Here, we share our insights from GMP inspections by foreign authorities and provide valuable recommendations on how to successfully pass your GMP inspection or audit. You will also periodically receive useful information about the Russian and Belarusian pharmaceutical markets and the market of the Eurasian Economic Union (EAEU). As enthusiastic pharmaceutical interpreters and GMP translators, we are excited to share valuable information about the history of the world's largest pharmaceutical manufacturers and their secrets to success.
New rules for conducting GLP inspections in the EAEU
The Council of the Eurasian Economic Commission has adopted new rules for conducting GLP inspections in research institutions. The aim is to ensure consistent Good Laboratory Practice (GLP) in the development of medicines.
These new rules are based on the practical experience of the member states of the Eurasian Economic Union (EAEU) and also take into account the international standards of the Organisation for Economic Co-operation and Development (OECD).
The aim is to standardise inspection procedures in order to prevent duplicate testing when authorising new drugs in the five EAEU states. The regulations also specify how risks must be assessed if deficiencies are identified.
The overall aim is to guarantee that only safe and thoroughly tested original medicines are authorised on the EAEU market.
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