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.
Although the EU GMP Annex 1 is a European guide for manufacturing, it has a global impact. For a sterile medicinal product to be imported into Europe after being manufactured elsewhere, the same practices must be implemented in these manufacturing facilities.
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.
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Image Credit: Sartorius Lab Instruments GmbH & Co. KG
About Sartorius Lab Instruments GmbH & Co. KG
The Sartorius Group is a leading international partner of life science research and the biopharmaceutical industry.
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.
The Bioprocess Solutions Division with its broad product portfolio focusing on single-use solutions helps customers to manufacture biotech medications and vaccines safely and efficiently. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions of complementary technologies.
In fiscal 2021, the company earned sales revenue of some 3.45 billion euros. At the end of 2021, nearly 14,000 people were employed at the Group’s approximately 60 manufacturing and sales sites, serving customers around the globe.
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