Sooner than many had expected, the ICH process is making progress. On 9
and 10 November, the ICH Steering Committee and its Expert Working Groups
held a meeting in Chicago.
The following results are of great interest for the GMP area.
1) Quality Systems - ICH Q10
The ICH Steering Committee adopted the topic of ICH Q10 officially.
As a consequence, in the next few months a Step-2 Guide will be developed
on the basis of the present internal draft. This guide is meant to link
the existing GMP rules in the USA, the EU and Japan with modern quality
system elements (among others ISO 9001) in the future. It will be
interesting to see to what extent the working group headed by Gerry
Migliaccio, Pfizer USA, will use the draft guide recently published by the
FDA (Quality System Approach to Pharmaceutical Current Good Manufacturing
Practices) as a basis. A Working
Group of ECA has worked out an answer to the question which overlaps
and differences exist between the EU-PIC/S GMP Guide, FDA's cGMP Guide and
ISO 9001.
2) Pharmaceutical Development - ICH Q8
ICH Q8 describes which data and information on pharmaceutical development have to be handed
in to the registration authorities according to the relevant
section in the Common Technical
Document. ICH Q8 is now finalised and thus in Step 4. Step 5 does not
include any changes to the content.
|
