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
