Executive summary

ICH Q9 QUALITY RISK MANAGEMENT

Quality
Risk Management
ICH Q9
Executive summary
for competent authorities and industry
Disclaimer: This presentation includes the author’s views on quality risk management theory and practice.
The presentation does not represent official guidance or policy of authorities or industry.
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

The situation today

The situation today for both regulators and industry
> Increasing external requirements
> Increasing efforts and costs
> Growing complexity and scope of risks
Empowerment & Flexibility is needed
> Master complexity and streamline decision making
> Proactive disclosure build trust and understanding
> Improve communication through sharing best practice
and science based knowledge
> Convert data into knowledge
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

New Regulatory Paradigm

• ICH Regulators:
> FDA: New paradigm with the 21st Century GMP initiative
> EMEA: Revised EU directives
> MHLW: Revised Japanese law (rPAL)
• EU & Japan became involved at ICH
GMP Workshop in July 2003: 5 year vision agreed:
“Develop a harmonised pharmaceutical quality system applicable
across the life cycle of the product emphasizing an integrated approach
to quality risk management and science”
• Consequent ICH Expert Working Groups (EWG):
> ICH Q8, on Pharmaceutical Development, doc. approved 2005
> ICH Q9, on Quality Risk Management, doc. approved 2005
> ICH Q10, on Quality Systems, topic accepted 2005
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 3
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

The new paradigm

“risk-based”
concepts and
principles

Q8
Q9 Q10
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 4
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

Incremental steps
Pharmaceutical Development (Q8)
Changed Past: Data transfer / Variable output
Paradigm Present: Knowledge transfer / Science
based / Consistent output

Quality Risk Management (Q9)

Past: Used, however poorly defined
Present: Opportunity to use structured
process thinking

Pharmaceutical Quality Systems (Q10)

Q10

Past: GMP checklist

Q8

Future: Quality Systems across product

Q9

life cycle

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 5
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT CONSIDERATIONS

Process
Understanding
Process Process
Understanding Understanding
CMC CMC
regulatory
regulatory
Oversight CMC CMC
regulatory
(Submission)
oversight regulatory
Oversight
CMC
(Submission)
oversight regulatory
oversight
cGMPcGMP
regulatory
cGMPcGMP
regulatory
regulatory
oversight
(Inspection)
oversight
Q8 regulatory
oversight Q10 cGMP
regulatory
oversight
& (Inspections)
oversight
&
Company’s Q9 Company’s Q9 Company’s
Quality system Quality system Quality system

Post Continuous
Approval
approval
Change Improvement
PAC to
PAC to
change
(PAC)
Continuous
Continuous
Improvement Risk
Improvement
Risk
(perceived Risk
(P/R)& real)
Based on A. Hussain, FDA, September 2004
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 6
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

The Desired State driven by ICH Q9

• Manage risk to patient, based on science:

> Product, process and facility
> Robustness of Quality System
> Relevant controls to assess & mitigate risk

• Level of oversight required commensurate

with the level of risk to patient for:
> Marketing authorisation applications
> Post-approval change review
> GMP inspections

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 7
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

The Desired State

• Barriers to continuous improvement

reduced or removed
> Improved manufacturing efficiency
> Sustained or improved product quality

• Specifications based on parameters

that truly impact product quality

• Common understanding and language on risk

• Both, industry and competent authorities focus on

areas of greatest risk and understanding of residual
risks
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 8
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

Pharmaceutical industry and quality risk management

• Pharmaceuticals have lagged behind related

industries in adopting structured risk management in
the quality area; e.g.
> Medical devices have ISO 14971
> Food industry uses HACCP

• We are using quality risk management but

> Implementation is patchy
> It is often not fully integrated with rest of the
Quality System

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 9
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

Advantages of quality risk management as technique

• Improves decision making
> Identifies what gives most benefit to the patient
• Is scientific & data-driven
> Reduces subjectivity
• Ranks risk - allows prioritization
> Better use of resources
• Means of building in Quality
• Improves transparency - inside organisation and
builds trust with competent authorities
> Enables regulatory flexibility
• Benefits apply throughout product lifecycle
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 10
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

Why did we need ICH Q9?

• To ensure a common understanding of

Quality Risk Management (QRM) among
industry and competent authorities

• To facilitate moving to the “Desired State”

> To facilitate communication and transparency
> To move from ‘fire fighting’ to management of risk

• ICH Q9 explains
> A common language and process
> Potential methodologies for QRM
> Where QRM can add value
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 11
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

Quality Risk Management is NOT

• Hiding risks

• Justifying poor quality of product and / or

processes

• Excusing industry’s obligation

to comply with regulatory requirements

HOWEVER

• It might bring about the revision or withdrawal of

some non risk base guidance

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 12
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

What does Senior Management need to do?

• Ensure organisation is aware of ICH Q9

and the opportunity it affords
> Appropriate education and training

• Encourage open, risk aware culture

> Establish & support “QRM leaders” across organisations

• Encourage integration of Quality Risk Management

with existing Quality systems
> Do NOT set up as a separate department
> Coordinate implementation and resource allocation
> Prioritise; start small, learn as you go
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 13
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

Conclusions
• ICH Q9, together with “Pharmaceutical development”
(ICH Q8) and “Quality systems” (ICH Q10), provides
opportunity for a revised, optimised and, less restrictive
regulatory paradigm
> Based on scientific knowledge
> Enable continuous improvement
> Greater transparency and efficiency
> Focusing on things that add value for patients
> Improved relationship between industry and competent
authorities based on trust
• We must seize this opportunity
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 14
Executive summary
ICH Q9 QUALITY RISK MANAGEMENT

Keep always in mind the

Principles of Quality Risk Management

The evaluation of The level of effort,

the risk to quality formality and
should be based on documentation
scientific knowledge of the quality risk
and ultimately link management process
to the protection should be commensurate
of the patient with the level of risk

ICH Q9

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 15
Executive summary Focus resources
ICH Q9 QUALITY RISK MANAGEMENT

where they matter most to protect the patient

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 16