EU-GMP Guide Annex 1 (Sterile Medicinal Products) to Be Revised

GMP News No. 273

GMP News
17 December 2002

EU-GMP Guide Annex 1(Sterile Medicinal Products) to Be Revised

On 20 November 2002, the EU Commission published a new Draft for Annex 1.The Draft had already been elaborated on 4 July on the occasion of the adhoc meeting of inspectors; however, it was published only inNovember. 

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.

Oliver Schmidt



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