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
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