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GMP News No. 550
25 April 2005
ICHQ8 "Pharmaceutical Development" –
In November 2004 the Q8 Guideline (1) was released for consultationunder Step 2 of the ICH process.
What was the background idea for developing guidance for pharmaceuticaldevelopment?
At the July 2003 ICH meeting in Brussels an arrangement was reached ona common vision and approach for developing an international plan for a harmonizedpharmaceutical quality system that would be applicable across the lifecycle of a product. Among other actions that were outlined to implementthis vision, an expert working group was established to develop guidancefor pharmaceutical development, which will cover the lifecycle of aproduct.
The ICH Q8 guideline is (…) is intended to provide guidance on thecontents of Section 3.2.P.2 (Pharmaceutical Development) for drug productsas defined in the scope of Module 3 of the Common Technical Document (ICHtopic M4). (…) The aim of pharmaceutical development is to designa quality product and the manufacturing process to deliver the product ina reproducible manner. (…) Information from pharmaceuticaldevelopment studies is a basis for risk management. It is important torecognize that quality cannot be tested into products (…) (see ICHQ8, Step 2 (1)).
The Q8 document has 12 pages and is structured according to thechapters as already defined in the ICH M4 CTD document:
Table of Contents of the Draft Consensus Guideline 'PharmaceuticalDevelopment Q8', Step 2 of the ICH Process, 18 November 2004
Dr. Fritz Erni, EFPIA representative on the ICH Q8 expert working groupstated that "(…) the agreement on the new guideline mayeventually be seen as a major sep towards achieving the common vision andapproach for developing an international plan for a harmonisedpharmaceutical quality system that was agreed during the July 2003 ICHmeeting in Brussels by industry and regulatory authorities (…). (3).He summarized the most important points of the guidelines as follows (3):
ICH Q8 – that is open for public consultation until June 2005 – isexpected to "(…) open the door for new opportunities inpharmaceutical manufacturing and quality assurance (and) is a stepaway from end-product testing to quality by design with the opportunityfor continuous improvement (3).
If you want to get detailed information about the significance of theICH Q8 document, you are invited to participate in the European GMPConference that has been organised on behalf of the University ofHeidelberg.
The conference will take place from 20-21 June 2005 in Heidelberg andis organised into 2 parts:
If you are interested in the detailed conference programme, pleaseclick here
Literature and Hyperlinks: