Pharmaceutical Regulatory Affairs: Open Access

Department of Materials Science, A.A. Baikov Institute of Metallurgy and Materials Science, Russian Academy of Sciences, Moscow, Russia

Publications

• Research Article   
  EU GMP Annex 1 of 2022: A View in Depth
  Author(s): Alexander Fedotov*
  
  The latest version of EU GMP Annex 1 was approved in August 2022 after a very long period of discussions [1]. People can expect that regulatory innovations are steps forward in quality assurance of medicinal products. But is it really so? Many presentations describe changes as to be progressive without explaining in depth. If to do so, one can see huge confusions in Annex 1 regarding requirements for cleanrooms. It is a pity that those who made changes ignored results of investigations [2,3], that were submitted to EU GMP Commission. New confusions were added to old contradictions and dogmas. A look in depth allows to understand whether changes are positive or they even jeopardize quality of products... Read More»
  

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