Catalogs >
Sartorius Group >
EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers

EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers
4Pages

Catalog excerpts

EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers - 1

EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers Med-Tech Innovation News | On the cover | Issue 61 | September-October 2022 After the latest revision to EU GMP Annex 1 in 2020, Eric Clement Arakel, Global Product Manager, and Myriam Gueye, Segment Marketing Manager, Applied Industries at Sartorius, explain the effect the newest form of the guidance has on both medical device and pharmaceutical manufacturers. The first version of the guidance dates back to 1971 and though there were multiple revisions up until 2010, this was the year when everyone took stock on what the guidance should look like. The document has expanded over the years, from 16 to over 50 pages and was finalized in August 2022 by the European Commission. So, how does it affect medical device manufacturers? Though it is a European guide for manufacturing, EU GMP Annex 1’s impact is global. As soon as a sterile medicinal product is imported into Europe having been manufactured elsewhere, the same practices must be adopted in these manufacturing facilities too. What drives the spirit of EU GMP Annex 1 is Quality Risk Management and Contamination Control Strategy. Though it is mostly directed at the manufacturer of sterile medicinal products, it’s also important to remember there are a lot of useful aspects for non-sterile manufacturing—including prompts and recommendations. For more information, please visit: www.sartorius.c

Open the catalog to page 1

EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers - 2

(left) Eric Clement Arakel Global Product Manager, Sartorius (right) Myriam Gueye Segment Marketing Manager, Applied Industries, Sartorius The Annex 1 contains several major revisions with many references to the implementation of Quality Risk Management as a more proactive approach rather than reactive. The document also highlights the importance of a contamination control strategy and covers 16 different elements, including cleanroom design and qualification, environmental monitoring, and several other areas. Section 4, concerning the facility, stipulates that the manufacture of sterile...

Open the catalog to page 2

EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers - 3

The document clearly specifies that all interventions caused by the environmental monitoring operation be avoided at all costs. One of the most common interventions is the routine retrieval of impaction plates from volumetric air samplers to avoid dehydration. This is where the MD8 Airscan® from Sartorius comes into its own. Paired with gelatine membrane filtration, cleanrooms can be monitored for a tested period of eight hours, typically the length of an entire manufacturing shift. By circumventing routine intervention, the technology is fully compliant with the requirements of the Annex 1...

Open the catalog to page 3

EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers - 4

therefore falls under the guidance. Implants containing medicinal products whose primary purpose is to release the medicinal product also fall under EU pharmaceutical legislation. In July 2021, the European Medicines Agency (EMA) adopted a guideline for medicinal products when used with a medical device. This guideline considers the three different configurations of medicinal products (integral, co-packaged, or referenced) and also the impact of the device on the critical quality attributes (CQA) and overall control strategy in the medicinal product dossier. View the Med-Tech Innovation...

Open the catalog to page 4