13/14 April 2021
GMP News No. 273
17 December 2002
EU-GMP Guide Annex 1(Sterile Medicinal Products) to Be Revised
Annex 1 to the EU-GMP Guide defines therequirements on sterile medicinal products. It is the aim of the revisedAnnex 1 to harmonise the environmental requirements for cleanrooms. Withthis document, the EU-GMP Inspectors react to the release of ISO 14644-1.
In our News of 3 May this year, we had already reported about the contents of ISO14644-1. The introduction of this new standard, which is now valid allover the world, had also induced FDA to substitute it for the FederalStandard 209 E.
The revision of Annex 1 coincides withthe new FDA Draft "Guideline on Sterile Drug ProductsProduced by Aseptic Processing."
If you would like to download the Draftfor Annex 1, please click here.