ICH Q8 and ICH Q9 Coming Soon!

GMP News No. 369

GMP News
10 December 2003
 

ICH Q8 and ICH Q9 Coming Soon!

 
To date there has only been one GMP guideline that has been harmonised in the US, Europe, and Japan: ICH Q7A "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients." Now, ICH is getting further "Q" Guidelines under way. We have reported about the background for this initiative in our GMP News of 6 August 2003. Due to its reforming "cGMP for the 21st Century" initiative, the US-American FDA had put the introduction of a risk-based GMP approach as well as the harmonisation of GMP requirements on the agenda. The International Conference on Harmonisation, which consists of representatives of the triad's authorities (i.e. FDA in the US, EMEA in the EU, and MHLW in Japan) and pharmaceutical associations (PhRMA, EFPIA, and JPMA), has now reacted to the initiative. Apart from these members, Canada, the World Health Organisation (WHO), and the European Free Trade Area (EFTA, represented by Dr Spang of the Swiss authority Swissmedic) participate in ICH as observers.
On the occasion of the ICH6 Conference in Osaka on 15 November, it has now been decided to develop the guidelines:
  • ICH Q8 Pharmaceutical Development - Quality by Design
  • ICH Q9 Risk Management

to harmonise them and to implement them in the regions USA, Europe, and Japan. Establishing an ICH standard in the triad requires the following steps:

Step 1 Consensus Building
Step 2 Start of Regulatory Actions
Step 3 Regulatory Consultation
At this point the document is already published: in Europe as a Draft CPMP Guideline by EMEA, in the US as a Draft Guidance in the Federal Register by FDA, and in Japan as a Draft Guidance by MHLW.
Step 4 Adoption of a Tripartite Harmonised Text
Step 5 Implementation

Owing to the planned publication, it is probable that in the future ICH will not only provide for the worldwide harmonisation of requirements regarding the marketing authorisation (like the Common Technical Document), but also of quality- and GMP-relevant documents.

In order to do justice to the importance of these topics, ECA has been focussing its attention on them for some time now.
    

The Top Event on Pharmaceutical Development in Vienna
On 11 and 12 March 2004, we repeat our GMP Education Course "Pharmaceutical Development" in Vienna, among others with EMEA Inspection Group Member David John Cockburn. He is co-author of the revised Annex 13. Dr Norman C. Franklin, a former ICH Q7A Expert Group Member, will also give several lectures. You can find the programme here. Please register early because the number of participants is strictly limited for this course!
 
Source: Press Release on ICH6 in Osaka

Author:
Oliver Schmidt
CONCEPT HEIDELBERG
  

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