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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 ad
hoc meeting of inspectors; however, it was published only in
November.
Annex 1 to the EU-GMP Guide defines the
requirements on sterile medicinal products. It is the aim of the revised
Annex 1 to harmonise the environmental requirements for cleanrooms. With
this 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 ISO
14644-1. The introduction of this new standard, which is now valid all
over the world, had also induced FDA to substitute it for the Federal
Standard 209 E.
The revision of Annex 1 coincides with
the new FDA Draft "Guideline on Sterile Drug Products
Produced by Aseptic Processing."
If you would like to download the Draft
for Annex 1, please click here.
Author:
Oliver Schmidt
CONCEPT HEIDELBERG
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