Implementation of ICH Q8, Q9, Q10
Q-IWG
Status update
Georges France
International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use
ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
Disclaimer
The information within this presentation is based on
the ICH Q-IWG members expertise and experience,
and represents the views of the ICH Q-IWG members
for the purposes of a training workshop.
© ICH, Washington, D.C., October 2010
© ICH, October 2010, Q-IWG Status update
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
ICH Q8, Q9 & Q10
A real opportunity
Benefit of a New Paradigm
- A life cycle approach: A focus investment during the
development with the benefit at the manufacturing
- Process Understanding
- Process Capability and Robustness
- Increase confidence between industry and regulators
- Continuous improvement changes
- Facilitate innovation and new technology (RMM, PAT,…)
- Increased flexibility to implement
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© ICH, Washington, D.C., October 2010
ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
Scenario
Potential Opportunity
1. Comply with GMPs
Compliance – status quo
2. Demonstrate effective pharmaceutical
quality system, including effective use
of quality risk management principles
(e.g., ICH Q9 and ICH Q10).
Opportunity to:
3. Demonstrate product and process
understanding, including effective use
of quality risk management principles
(e.g., ICH Q8 and ICH Q9).
Opportunity to:
4. Demonstrate effective pharmaceutical
quality system and product and
process understanding, including the
use of quality risk management
principles (e.g., ICH Q8, ICH Q9 and
ICH Q10).
Opportunity to:
o increase use of risk based approaches for regulatory
inspections.
o facilitate science based pharmaceutical quality
assessment;
o enable innovative approaches to process validation;
o establish real-time release mechanisms.
o increase use of risk based approaches for regulatory
inspections;
o facilitate science based pharmaceutical quality
assessment;
o optimise science and risk based post-approval
change processes to maximise benefits from
innovation and continual improvement;
o enable innovative approaches to process validation;
o establish real-time release mechanisms.
© ICH, Washington, D.C., October 2010
© ICH, October 2010, Q-IWG Status update
ICH Q10, Annex I
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
Scenario
Potential Opportunity
2. Demonstrate effective
pharmaceutical quality system,
including effective use of quality risk
management principles
(e.g., ICH Q9 and ICH Q10).
Opportunity to:
o increase use of risk based approaches for
regulatory inspections.
ICH Q10, Annex I
© ICH, Washington, D.C., October 2010
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
Scenario
Potential Opportunity
3. Demonstrate product and
process understanding, including
effective use of quality risk
management principles
(e.g., ICH Q8 and ICH Q9).
Opportunity to:
o facilitate science based pharmaceutical
quality assessment;
o enable innovative approaches to process
validation;
o establish real-time release mechanisms.
© ICH, Washington, D.C., October 2010
© ICH, October 2010, Q-IWG Status update
ICH Q10, Annex I
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
Scenario
Potential Opportunity
4. Demonstrate effective pharmaceutical
quality system and product and process
understanding,
including the use of quality risk
management principles (e.g., ICH Q8,
ICH Q9 and ICH Q10).
Opportunity to:
o increase use of risk based approaches for
regulatory inspections;
o facilitate science based pharmaceutical quality
assessment;
o optimise science and risk based postapproval change processes to maximise
benefits from innovation and continual
improvement;
o enable innovative approaches to process
validation;
o establish real-time release mechanisms.
© ICH, Washington, D.C., October 2010
ICH Q10, Annex I
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
ICH Q8, Q9 & Q10: A real opportunity
• QbD, a reality:
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Application including elements of a QbD
In EU (Tallinn update)
- 14 centralised approved product application
In US (Washington update)
- In CMC pilot 10 NDAs & 3 sNDAs
- Outside pilot 22 INDs, 22 NDAs, 5 sNDAs
Quality by design : A cultural change
Global Harmonisation within and outside ICH region
© ICH, Washington, D.C., October 2010
© ICH, October 2010, Q-IWG Status update
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
A cultural change challenged by globalisation
outside ICH region
• Step by step approach: Learning by doing
• Support of the implementation is required
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From the theory to the practical aspect
Clarifying in Q&A
Training / workshop
• Role and value of
Quality-Implementation Working Group (Q-IWG)
© ICH, Washington, D.C., October 2010
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
ICH Q-IWG: Achievements
• Q&A 45 already done
• Cooperation outside the 3 ICH Regions facilitated by the
Global Cooperation Group (GCG) in ICH
• Working on External Collaboration with other not-forprofit organisation
e.g. PIC/S, PDA (PCMO), ISPE (PQLI),…
• Major and unique Training/Workshop
© ICH, Washington, D.C., October 2010
© ICH, October 2010, Q-IWG Status update
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
Q-IWG Achievements: Q&A
• This Questions and Answers document (Q&A) are
there to support the harmonised implementation the
guidelines of ICH Q8, Q9 and Q10
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Brussels
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Yokohama June 09
New Q&A ICH SC approval: June 2009
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St Louis
New Q&A ICH SC approval: October 2009
Oct 08
Oct 09
First Q&A ICH SC approval: April 2009
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© ICH, Washington, D.C., October 2010
ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
Q-IWG: Q&A Status
For general clarification
Quality by Design (QbD) topics
- Design Space
- Real Time Release Testing
- Control Strategy
Pharmaceutical Quality System
GMP Inspection practice
Knowledge Management
Software solution
Total
© ICH, Washington, D.C., October 2010
© ICH, October 2010, Q-IWG Status update
currently
3
1
8
11
5
8
3
5
1
45
open
+3
+3
+8
+1
+15
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
This ICH Q-IWG Training / Workshop:
What is the difference?
• Only 3 workshops endorsed and operated by the ICH Q-IWG
• A story based on a case study, on the life cycle aspect. Development
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assessment manufacturing and inspection
The same workshop will be offered by the same faculty in each of the three
ICH regions.
All attendees to participate in the breakouts on each life
Report back for future Q-IWG Q&A development
Workshop materials will be published by ICH and can be used for internal
training by authorities (assessors and inspectors) and industry
The idea behind: to illustrate the concept of enhanced approach, which
can be apply from simple to complex molecule
Complexity of the scheme …
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© ICH, Washington, D.C., October 2010
ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Key
Steps
for
a product under Quality by Design (QbD)
Q-IWG
Status
update
Pharmaceutical
Development
Quality Target
Product Profile
Prior Knowledge (science, GMP,
regulations, ..)
CQA : Critical
Quality Attribute
Product/Process Development
CPP : Critical
Process Parameter
DOE : Design of Experiment
QTPP : Definition of intended use & product
Potential CQA (Critical Quality Attribute) identified &
CPP (Critical Process Parameters) determined
Design to meet CQA using Risk Management &
experimental studies (e.g. DOE)
Link raw material attributes and process parameters
to CQAs and perform Risk Assessment Methodology
QRM principle apply at any stage
Risk Management
Product/Process Understanding
Opportunities
Design Space (DS), RTR testing
Control Strategy
Marketing Authorisation
Quality System PQS
Technology Transfer
PQS & GMP
Local Environment
© ICH, Washington, D.C., October 2010
Commercial Manufacturing
Batch Release
Strategy
Continual
improvement
© ICH, October 2010, Q-IWG Status update
Quality Unit (QP,..) level support by PQS
Manage product lifecycle, including
continual improvement
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
ICH Q-IWG: Future actions
• Evaluate training outcome from Tallinn, Washington & Tokyo
• Additional Q&A if needed
• Cooperation outside the 3 ICH Regions facilitated by the
Global Cooperation Group (GCG) in ICH
• Potential collaboration with other not-for-profit organisation
e.g. PIC/S, PDA (PCMO), ISPE (PQLI),…
• Consider possible gap/barrier on existing ICH Q guidelines
with the new paradigm: Review & proposed actions
© ICH, Washington, D.C., October 2010
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
Q-IWG Goals and Achievements: Outcome of the
training
Take away for you and for Q-IWG
• Key messages: clear or not
• Practical concerns of implementation
• Clarification required and addressed to Q-IWG
© ICH, Washington, D.C., October 2010
© ICH, October 2010, Q-IWG Status update
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ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
THANK
YOU
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© ICH, Washington, D.C., October 2010
ICH Quality Implementation Working Group - Integrated Implementation Training Workshop
Q-IWG Status update
Acknowledgement
This presentation has been developed by members of the ICH
Quality Implementation Working Group (IWG)
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Jean-Louis Robert (rapporteur)
Diana Amador-Toro
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Robert G. Baum
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Nicholas Cappuccino
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David Cockburn
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Georges France
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Richard L. Friedman
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Nigel Hamilton
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Hirotada Nagai
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Yukio Hiyama
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Fusashi Ishikawa
Takao Kiyohara
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Urs Kopp
Akira Kusai
Yoshihiro Matsuda
Motoaki Mitsuki
Elaine Morefield
Jacques Morénas
Masatoshi Morisue
Markus-Peter Müller
Tamiji Nakanishi
Moheb Nasr
• Kazuhiro Okochi
© ICH, Washington, D.C., October 2010
© ICH, October 2010, Q-IWG Status update
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Anthony Ridgway
Rachael Roehrig
Stephan Rönninger
Swroop Sahota
Hideki Sasaki
Tetsuhito Takarada
Shigeki Tamura
Krishnan Tirunellai
Mats Welin
Jean M. Wyvratt
A J van Zyl
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