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 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

   

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK