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

GMP News No. 550

Regulatory Affairs News
25 April 2005
 

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

 
In November 2004 the Q8 Guideline (1) was released for consultation under Step 2 of the ICH process.

What was the background idea for developing guidance for pharmaceutical development?

At the July 2003 ICH meeting in Brussels an arrangement was reached on a common vision and approach for developing an international plan for a harmonized pharmaceutical quality system that would be applicable across the life cycle of a product. Among other actions that were outlined to implement this vision, an expert working group was established to develop guidance for pharmaceutical development, which will cover the lifecycle of a product.

The ICH Q8 guideline is (…) is intended to provide guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4). (…) The aim of pharmaceutical development is to design a quality product and the manufacturing process to deliver the product in a reproducible manner. (…) Information from pharmaceutical development studies is a basis for risk management. It is important to recognize that quality cannot be tested into products (…) (see ICH Q8, Step 2 (1)).

The Q8 document has 12 pages and is structured according to the chapters as already defined in the ICH M4 CTD document:

Table of Contents of the Draft Consensus Guideline 'Pharmaceutical Development 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 group stated that "(…) the agreement on the new guideline may eventually be seen as a major sep towards achieving the common vision and approach for developing an international plan for a harmonised pharmaceutical quality system that was agreed during the July 2003 ICH meeting 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 for postapproval 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 – is expected to "(…) open the door for new opportunities in pharmaceutical manufacturing and quality assurance (and) is a step away from end-product testing to quality by design with the opportunity for continuous improvement (3).

    If you want to get detailed information about the significance of the ICH Q8 document, you are invited to participate in the European GMP Conference that has been organised on behalf of the University of Heidelberg.

    The conference will take place from 20-21 June 2005 in Heidelberg and is 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, please click here

    Literature and Hyperlinks:

    Abbreviations

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

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