European Commission Consults on Revised GMPs for Sterile Drugs
By Michael Mezher -
Published 20 December 2017
The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4.
Categories: News, Europe, EC, Drugs, Manufacturing
Tags: Eudralex Volume 4, Annex 1, Sterile Drugs, Good Manufacturing Practice, GMP
Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation
By Yvonne Middlefell, FRAPS, RAC -
Published 12 December 2017
This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use.
Categories: Features, Europe, EC, In vitro diagnostics, Labeling, Medical Devices, Submission and registration
Tags: IVDR, Annex 1, Risk Management