Following the most recent revision to the EU GMP Annex1 in 2020, Eric Clement Arakel (Global Product Manager) and Myriam Gueye (Segment Marketing Manager, Applied Industries) at Sartorius will explain the impact that this updated guidance has on pharmaceutical and medical device manufacturers.
The original version of the guidance was published in 1971, with many revisions taking place over the years. The document has since expanded from 16 pages to more than 50 pages, with the European Commission finalizing the document in August 2022.
The EU GMP Annex 1 is driven by a Quality Risk Management and Contamination Control Strategy. Despite this being largely directed at the manufacturers of sterile medicinal products, there are many useful aspects within the document for non-sterile manufacturing, such as prompts and recommendations.About Sartorius Lab Instruments GmbH & Co. KG
With innovative laboratory instruments and consumables, the Group’s Lab Products & Services Division concentrates on serving the needs of laboratories performing research and quality control at pharma and biopharma companies and those of academic research institutes.
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