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2.7 A Risk-Based Approach To Pharmaceutical Development

This document discusses ICH Q8, Q9, and Q10 guidelines and their role in a risk-based pharmaceutical development approach. It advocates using a thorough understanding of formulations and manufacturing processes to develop quality by design with built-in quality, using tools like Process Analytical Technology (PAT) and risk management. Real-time release testing is presented as an alternative to end-product testing that relies on in-process monitoring and prediction of quality attributes.

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Jorge Humberto Herrera
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157 views22 pages

2.7 A Risk-Based Approach To Pharmaceutical Development

This document discusses ICH Q8, Q9, and Q10 guidelines and their role in a risk-based pharmaceutical development approach. It advocates using a thorough understanding of formulations and manufacturing processes to develop quality by design with built-in quality, using tools like Process Analytical Technology (PAT) and risk management. Real-time release testing is presented as an alternative to end-product testing that relies on in-process monitoring and prediction of quality attributes.

Uploaded by

Jorge Humberto Herrera
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© © All Rights Reserved
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www.legemiddelverket.

no
A risk-based approach to pharmaceutical
development
ICH Q8/Q9/Q10
Oslo, January 29 2009
yvind Holte
Norwegian Medicines Agency
www.legemiddelverket.no
Q8
Q9
Q10
PAT
Formal Experimental Design
Real-Time
Release
Multivariate
Data Analysis
www.legemiddelverket.no
Formulation
development
ICH Q8, Q9, Q10 and Pharmaceutical Development
Product life cycle
Knowledge
Active ingredient
Formulation
Manufacturing process
development
Routine
manufacture
www.legemiddelverket.no
ICH Q8, Q9 and Pharmaceutical Development
Fundamental concept of ICH Q8, Q9:
Product quality should be built in by design
Enhanced approach versus minimal approach
to pharmaceutical development
www.legemiddelverket.no
ICH Q8, Q9 and Pharmaceutical Development
Enhanced approach to pharmaceutical
development
Thorough knowledge of the formulation/ product and
the manufacturing process
Risk- and science-based development of the
formulation and the manufacturing process
Establishment of a Design space
www.legemiddelverket.no
www.legemiddelverket.no
ICH Q8, Q9 and Pharmaceutical Development
Enhanced approach to pharmaceutical
development - Post-approval flexibility
Routine manufacture
Monitoring of the process and critical intermediates
Non-destructive real-time analysis
Feed-back or feed-forward controls
Flexible manufacturing process
Changes within design space
www.legemiddelverket.no
ICH Q8, Q9 and Pharmaceutical Development
ICH Q8
Minimal versus enhanced
approach to Pharmaceutical
development
Design space and interaction
effects between process
parameters
Control strategies, including
real-time release
Definition of key concepts
ICH Q9
Principles of quality risk
management
Quality risk management
process
Risk management tools/
methodology
Definition of key
concepts
www.legemiddelverket.no
ICH Q9: Risk
management
Continuous
process
spanning the
entire product
life cycle
www.legemiddelverket.no
Process Analytical Technology: A brief overview
Enhanced approach
to pharmaceutical
development
Built-in
quality by
design
Process Analytical
Technology
Fast
Non-destructive
www.legemiddelverket.no
Process Analytical Technology: A brief overview
Prez-Ramos et al. AAPS PharmSciTech 6(1) 2005
www.legemiddelverket.no
Process Analytical Technology
ICH Q8: PAT: A system for designing and
controlling manufacturing through timely
measurements (i.e. during processing) of critical
quality and performance attributes for raw and in-
process materials and also processes with the
goal of ensuring final product quality
www.legemiddelverket.no
Process Analytical Technology
Enhanced product quality control
Experimental
design
New analytical
tools (PAT)
+
A deeper understanding of the product and the manufacturing process
+
Risk
management
www.legemiddelverket.no
ICH Q8, Q9, Q10 and batch release
Examplain: Pharm.Tech Europe 18(12) (2006)
www.legemiddelverket.no
Examplain Risk management
www.legemiddelverket.no
Examplain Risk management
www.legemiddelverket.no
Examplain
www.legemiddelverket.no
Examplain Process control
www.legemiddelverket.no
Examplain Design Space
www.legemiddelverket.no
Examplain Control Strategy
www.legemiddelverket.no
Real-time release
The product specification still applies as for
traditionally released products
Conformance to the specification is
demonstrated in a different way: Not by end
control, but by prediction from information
elements obtained during manufacture
During shelf life, traditional testing applies
Selected tests may be substituted one by one,
resulting in a reduced end control scheme
www.legemiddelverket.no
Summary and Conclusion
Built in quality by design
Risk management
Enhanced pharmaceutical
development
PAT tools
Product life cycle
Development
Technology transfer
Manufacturing
Discontinuation
References
EMEA home page: PAT Q&A, EMEA PAT team
http://www.emea.europa.eu/Inspections/PAThome.html
FDA: PAT a framwork for innovative pharmaceutical development, manufacturing
and quality assurance (2004)
http://www.fda.gov/cder/guidance/6419fnl.pdf
Examplain: Pharm.Tech Europe 18(12) (2006)

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