What is the Annex 1 EU GMP?
Annex 1 of the EU GMP guidelines describes the European Union’s requirements for the manufacture of sterile medicinal products, including those imported from non-member nations. The latest revision, to be released in 2019, is expected to have a greater reaching impact on QA/QC and all laboratory activities.
Does EudraLex apply to medical devices?
Annex 11, you’ll notice that it only really applies to the production and distribution of medicinal products and not medical devices.
Who can use a Class 1 device?
Class 1 medical devices are devices with low or moderate risk to patient health and safety. 47% of approved medical devices are Class 1, and 95% of these devices are exempt from the PMA pathway to regulatory approval. Class 1 device manufacturers are required to register their device with the FDA, however.
What is EudraLex Volume 4 Annex 1?
EudraLex Volume 4, Annex 1 provides guidance for the manufacturing of sterile medicinal products that are intended for the European market. It has been updated several times, with the latest revision in 2008, but a fundamental review has not been carried out until now.
What is the Annex 1 revision group doing?
This group meets to discuss the Annex 1 revision and has developed Joint letters on areas where there is shared positions amongst all the associations. Two letters have been developed to date.
What is the EU GMP Annex 1?
The Current EU GMP Annex 1, Manufacture of Sterile Medicinal Products, is under revision by the EMA Inspector Working Group.
What is Annex 1 in QRM?
The updated version of Annex 1 emphasizes the application of QRM principles throughout the process of sterile manufacturing. This is to proactively and continuously identify, evaluate, address, control, and monitor potential risks of microbial, particulate, and pyrogen contamination.