ICH Q8 and Q9 Now Finalised - ICH Q10 on Quality Systems to Come

GMP News No. 636

GMP News
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.

 
We will inform you as soon as the ICH documents are available.

Author: Oliver Schmidt
on behalf of the European Compliance Academy

Source: www.ich.org (Press Release)

   

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