GMP News No. 636
21 November 2005
ICH Q8 and Q9 Now Finalised - ICH Q10 on Quality Systems to Come
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.
|A GMP Conference, among others with 2 ICH Q8 Expert Group Members as well as a speaker from EMEA, takes place in Madrid on 1 and 2 December. Apart from development, the new requirements on Investigational Medicinal Products will be a focus topic: New GMP/ICH Requirements on Development and IMPs (Investigational Medicinal Products)|
3) Quality Risk Management - ICH Q9
This guide contains principles and examples of Quality Risk Management
that can be applied to the areas of pharmaceutical development,
pharmaceutical production and inspections by supervisory authorities. ICH
Q9 is finalised as well, i.e. it has entered Step 4.
|Quality Risk Management and thus ICH Q9 has also to be applied to computer validation. A 2-day GMP Education Course "The Risk-Based Approach to Computer Validation" with the Chairman of the GAMP Forum, Dr David Selby, will take place in Berlin on May 8-9 2006.|
on behalf of the European Compliance Academy
Source: www.ich.org (Press Release)