ICH Q8 "Pharmaceutical Development" - Background and Important Aspects of Implementation

GMP News No. 550


Regulatory AffairsNews
25 April 2005

 ICHQ8 "Pharmaceutical Development" –
Background and Important Aspects of Implementation

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

  • Introduction
  • Objective of the Guideline
  • Background
  • Scope
  • Pharmaceutical Development
  • Components of the Drug Product
  • Drugs Substance
  • Excipients
  • Drug Product
  • Formulation Development
  • Overages
  • Physicochemical and Biological Properties
  • Manufacturing Process Development
  • Container Closure System
  • Microbiologial Attributes
  • Compatibility
  • Glossary

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):


  • there is no escalation of current requirement
  • it defines the baseline for any new submission according to the CTD
  • it defines optional opportunities for:
    regulatory flexibility
    continuous improvement; and
    real time release;
  • it opens the door for submitting quality by design data
  • it provides for optional update of P2 for adding knowledge forpostapproval change;
  • it defines what is a critical parameter; and
  • it defines 'design space' and what is and is not a change

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:

  • the Main GMP conference on 20 June 2005
  • two parallel conference day on 21 June 2005 about
        a. ICH Q8 Pharmaceutical Development
        b.  ICH Q9 Quality Risk Management

If you are interested in the detailed conference programme, pleaseclick here

Literature and Hyperlinks:


  • CTD Common Technical Document
  • EFPIA European Federation of Pharmaceutical Industries and Associations
  • ICH International Conference on Harmonization

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