EU GMP Guide Annex 6 "Manufacture of Medicinal Gases" Draft Revision published for Public Consultation

 
Annex 6 of the GMP Guide has been revised as a consequence of the restructuring of the GMP Guide and the need to review requirements of Part II of the Guide for the applicability to medicinal gases. The opportunity has also been taken to update the annex. Now it was published for the public consultation phase. Comments should be sent by the 31 December 2007 to entr-gmp@ec.europa.eu and GMP@emea.europa.eu.
 
Besides a general update with editorial changes, most modifications were made with regard to Part II of the Guide. Starting material and bulk pharmaceutical product are more clearly defined. The annex states that bulk gases could be regarded as an active substances used as starting materials or bulk medicinal products as decided by national competent authorities.
 
Manufacture of active substance gases should comply with the Basic Requirements of this guide (Part II), with the relevant part of this Annex, and with the other Annexes of the guide if relevant. Manufacture of medicinal gases should comply with the Basic Requirements of this guide (Part I), with the relevant part of this Annex, and with all the other Annexes of the guide if relevant.
 
The draft of the Annex is available at
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/2007_04_annex6-draft.pdf
 

 
Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)