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ICH Q9 QUAL ITY RISK MANAGEMENT
QualityRisk Management
ICH Q9
Background
Discla imer:This presentation includes the authors views on quality risk management theory and practice.
The presentation does not represent official guidance or policy of authorities or industry.
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ICH Q9 QUAL ITY RISK MANAGEMENT
Purpose of this part
To provide information on
the background
of the ICH Q9 document
Give an aid by providing some points of discussions
on the understanding of the quality risk management
concept
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ICH Q9 QUAL ITY RISK MANAGEMENT
Agenda
The ICH process
ICH Q9 and other ICH guidelines
From Risk to Quality Risk Management
Opportunities, Challenges and Benefit
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ICH Q9 QUAL ITY RISK MANAGEMENT
International Conferenceon Harmonisation
of TechnicalRequirements
for Registration of
Pharmaceuticals
for Human Use
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ICH Q9 QUAL ITY RISK MANAGEMENT
Expert Working
Groups EWG )
EWGs include observers and
constituted from both authorities & industry
Guidel ines on
QualityChemical andpharmaceutical QA
Safety
In vitro and in-vivo pre-clinical studies
EfficacyClinical studiesin human subject
MultidisciplinaryGeneral topics
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ICH Q9 QUAL ITY RISK MANAGEMENT
ICH Q9 Link back to patient risk
Process
Materials
Design
Manufacturing
Distribution
Patient
Facilities
Opportunities to impact
risk using quality risk
management
G.- Claycamp, FDA, June 2006
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ICH Q9 QUAL ITY RISK MANAGEMENT
Risk Management across the
Product lifecycle for drug (medicinal) productsResearch
Preclinical
PhaseClinical
PhasesLaunch
QualityICH Q9
Safety
Efficacy
Manufacturing
& Distribution
GLP
GCP
GMP
GDP
End oflife cycle
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ICH Q9 QUAL ITY RISK MANAGEMENT
Source:basic model adapted from FDA (1999). Managing the Risks from Medical Product Use.
Managing the risk of drug
(medicinal) product use
Known Side Effects
Avoidable Unavoidable
Medication or DeviceError
Product Defects
PreventableAdverseEvents
Injury orDeath
UnexpectedConsequences
Public Health
CONSIDERATIONS
ICH Q9
Safety
Efficacy
Quality
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ICH Q9 QUAL ITY RISK MANAGEMENT
New Regulatory Paradigm
ICH Regulators:
> FDA: New paradigm with the 21stCentury GMP initiative
> EMEA: Revised EU directives
> MHLW: Revised Japanese law (rPAL)
EU & Japan became involved at ICHGMP Workshop in July 2003: 5 year vision agreed:
Develop a harmo nis ed pharmaceut ical qual i ty system appl ic ableacross th e l i fe cyc le of the produ ct emphasizing an integrated approach
to qu ali ty r isk 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
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ICH Q9 QUAL ITY RISK MANAGEMENT
r isk-based
concepts and
pr incip les
The new paradigm
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ICH Q9 QUAL ITY RISK MANAGEMENT
Pharmaceutical Development (Q8)
Past: Data transfer / Variable output
Present: Knowledge transfer / Science
based / Consistent output
Pharmaceutical Quality Systems (Q10)
Past: GMP checklist
Future: Quality Systems across product
life cycle
Quality Risk Management (Q9)
Past: Used, however poorly defined
Present: Opportunity to use structured
process thinking
Incremental steps
Changed
Paradigm
Q9
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ICH Q9 QUAL ITY RISK MANAGEMENT
How Q9 interacts with Q8 and Q10
Base: J. Ramsbotham, Solvay Pharm. NL / EFPIA
Riskfro
mM
anufacturingsite
Product / Process Risk
High
Low
HighLow
Using Q9
Quality Risk
Managementprinciples
contin
uali
mprov
em
ent
Q10
Pharm.
Quality
Systems
Q8 Pharmaceutical Development
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ICH Q9 QUAL ITY RISK MANAGEMENT
Q10Q8
ICH Q9 Link back to patient risk
Process
Materials
Design
Manufacturing
Distribution
Patient
Facilities
Opportunities to impact
risk using quality risk
management
G.- Claycamp, FDA, June 2006
Q9
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ICH Q9 QUAL ITY RISK MANAGEMENT
A Vision of the future becomes fact
Old Approach New Approach Remarks
Broad Concept
Quality decisions divorced
from science and risk
evaluation.
Adherence tofiling
commitments.
Quality decisions and filing
committments based on
Process Understanding
and Risk Management.
Quality by Design.
Design Spaceconcept
introduced to integrate
process knowledge with
regulatory evaluation.
Quality
Post-factumsampling and
quality testing.
Process Validation.
Management of variabi lity
Process control focused on
critical attributes.
Continuous Quality
Verification.
Quality by designdefinition
applied. Measure critical
process parameters to control
output product quality.
Systems
Systems designed to inhibit
changes & minimize business
risks. Discouragesimprovement & innovation.
Changes managed within
company's quality system.
Real time batch releasefeasible.
Regulators and industry place
higher reliance / trust /
understandingon systems.Multidisciplinary evaluation
and decision making.
Regulatory
Compliance focus.
Changes require prior
approval.
Regulatory scrutiny adjusted
to level of Process
Understanding. Continuous
improvement allowed
within Design Space.
Requires mechanisms to
communicate Process
Understanding data
("inspectable rather than
reviewable") .
Based on EFPIA, PAT Topic Group, 2005
CONSIDERATIONS
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ICH Q9 QUAL ITY RISK MANAGEMENT
Continuous
Improvement
Process
Understanding
Risk
CMCregulatoryoversight
Companys
Quality system
cGMPregulatoryoversight
Continuous
Improvement
Process
Understanding
Risk
CMCregulatoryoversight
Companys
Quality system
cGMPregulatoryoversight
Q8&
Q9
Based on A.Hussain, FDA, September 2004
Q10&
Q9
Process
Understanding
Risk(P/R)
CMC
regulatory
oversight
Companys
Quality system
cGMP
regulatoryoversight
Postapproval
change
Process
Understanding
Risk(perceived & real)
CMC regulatory
Oversight
(Submission)
Companys
Quality system
cGMP regulatory
oversight(Inspection)
PostApproval Change
(PAC)PAC to
Continuous
Improvement
Process
Understanding
Risk
CMC
regulatory
oversight
Companys
Quality system
cGMPregulatory
oversight
PAC toContinuous
Improvement
Process
Understanding
Risk
CMC regulatory
Oversight
(Submission)
Companys
Quality system
cGMP regulatoryoversight
(Inspections)
CONSIDERATIONS
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ICH Q9 QUAL ITY RISK MANAGEMENT
Agenda
The ICH process
ICH Q9 and other ICH guidelines
From Risk to Quality Risk Management
Opportunities, Challenges and Benefit
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ICH Q9 QUAL ITY RISK MANAGEMENT
ICH Q9
Quality Risk Management
What does it mean?
What is it worth?
Where does it lead?
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ICH Q9 QUAL ITY RISK MANAGEMENT
Managing risk is a behavior
The investigation of risks
is at once
a scientific activity and
an expression of culture
Kasperson, Renn, Slovic et al. (1988)
CONSIDERATIONS
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ICH Q9 QUAL ITY RISK MANAGEMENT
Risk Management as a discipline
provides multiple benefits Understand and influence the factors(hazards)
which impact regulators and industry business
Create awareness and a culture
> Supports an effective pro-active behaviour
> Open factual dialogue
> Make decisionstraceable and consistent
Provide assurance
> Risks are adequately managed
> Complianceto external and internal requirements
Recognise risks at a desired level> Zero risk not possible
CONSIDERATIONS
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ICH Q9 QUAL ITY RISK MANAGEMENT
?
The HurdlesIncreasingexternal
requirementsfor best practice,
transparency andcompliance
Public / Community
Governments
Regulators
PatientsInvestors / Creditors
Growing
complexityand scope of risks
Globalisation
Multinational
Multi-factor approaches
Regulatory expectations
Acceptance of
risk and uncertainty
Increasing
effortsand costsfor sustainability
Documentation
Projects
Systems
InterfacesBased on D. Geller, Roche
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ICH Q9 QUAL ITY RISK MANAGEMENT
QualityRisk
Management
Empowerment & Flexibility
Proactive
disclosurebuild trust and
understanding
Improvecommunication
through sharingbest
practice and science
based knowledge
An appropriate integrated approach
helps to meet requirements more efficiently
Master complexityConvert data into knowledge
e.g. by using methodology and toolsBased on D. Geller, Roche
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ICH Q9 QUAL ITY RISK MANAGEMENT
Different meaning of risk
Individual
> Risk is a cognitive and emotionalresponse to expected loss
Technicians
> Risk is usually based on the expected valueof the
conditional probability of the event occurringmultiplied by
the consequences of the event given that it has occurred
ICH Q9
> Combination of the probabilityof occurrence of harm and
the severityof that harm
CONSIDERATIONS
Based on G. Claycamp, FDA, September 2005
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ICH Q9 QUAL ITY RISK MANAGEMENT
Different meaning of risk
Organizations might use many different meaningsof risk
> Depending on the type of risk management program
In general, "probability" and "severity" must be considered
> In a given program definitions will fine-tune the conceptsso that arisk management programcan be created
and applied
> Make the detail in the definition fit the objective
of the program
Accept the different "realities"among the stakeholders
> Harmonized guidance needs to focus concepts
into useful terms for the purpose (e.g. protection of patient [Q9])
CONSIDERATIONS
Based on G. Claycamp, FDA, September 2005
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ICH Q9 QUAL ITY RISK MANAGEMENT
Severityand Probabi l i ty are simple concepts?
Which consequence is more severe?
> 300 lives lost in single, fiery plane crash.
> 300 lives lost on US roads over a weekend.
> 300 livespotentiallylost from cancer within the next 20 years
Which probability is probable?
What does a 30% chance of rain tomorrow mean?
> 30% of the days like tomorrow will have at least a trace of rain.
> 30% of the area will have rain tomorrow.
> 30% of the time tomorrow, it will rain. Gigerenzer, et. al (2005)
G. Claycamp, FDA, September 2005
CONSIDERATIONS
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ICH Q9 QUAL ITY RISK MANAGEMENT
The risk-based approach
severity
probabilityParameters
for
evaluating risks
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ICH Q9 QUAL ITY RISK MANAGEMENT
Parameters for calculating risks
A picture of the life cycle
Probabi l i ty Detectabi l i ty Severity
past today future
Refersto
time
Refersto
Refersto
= Risk Priority Number
x x
CONSIDERATIONS
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ICH Q9 QUAL ITY RISK MANAGEMENT
(Dis)Advantage calculated numbers & data
Numbers
> Does the Risk Priority Number tell the truth?
Keep a robust data set for further evaluation!
> Is the data set comparable?
> Are the data plainand concise?
> What about trendingand use of statistics
including extrapolation?> What amount of datais enough?
e.g. start with the existing data set
CONSIDERATIONS
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ICH Q9 QUAL ITY RISK MANAGEMENT
Hazards in QualityAnything
that has the potential toharm patients,
product quality or
the business
(loss, interruption, image)
CONSIDERATIONS
S. Rnninger, Roche, 2004
Potential threat
- chemical reaction
- manufacturing issues
- facilities and equipment
System defect- not detected- insufficiently prevented
- emerges by degree
Failure
- technical breakdown- human breakdown
- extrinsic effect
hazard
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ICH Q9 QUAL ITY RISK MANAGEMENT
Risk and Uncertainty
Time
ProcessPa
rame
ter
Lower Specification Limit (LSL)
Upper Specification Limit (USL)
today
Uncertainty
RISK: For a given sever i ty of r isk event, what are the chances
(prob abi l i ty) of exceeding th e USL in the next per iod o f t ime?
G. Claycamp, FDA, Sept. 2005
CONSIDERATIONS
Tomorrow ?
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ICH Q9 QUAL ITY RISK MANAGEMENT
Risk and Uncertainty
Different Risk Management Control?
Time
ProcessP
ara
me
ter
Lower Specification Limit (LSL)
Upper Specification Limit (USL)
today
Uncertainty
RISK: Contro l opt io ns are scenar ios for r isk management. Note
that this scenar io show s the best est imate is below the USL.G. Claycamp, FDA, Sept. 2005
CONSIDERATIONS
Tomorrow ?
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ICH Q9 QUAL ITY RISK MANAGEMENT
Risk and Uncertainty
Is the Risk of Exceeding USL = Zero?
Time
P
rocessP
aram
eter
Lower Specification Limit (LSL)
Upper Specification Limit (USL)
today
Uncertainty
Take a cut at a
moment in time:
Risk has a distribution.G. Claycamp, FDA, Sept. 2005
CONSIDERATIONS
Tomorrow ?
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ICH Q9 QUAL ITY RISK MANAGEMENT
Uncertaintyand Quality Risk Management
CONSIDERATIONS
Hazard
may
cause harm
Hazard
may not
cause harm
uncertainty
Hazard
is less likely to
cause harm
Manage risksin relation to
probability &
severity
Lack of, or inadequate knowledge
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ICH Q9 QUAL ITY RISK MANAGEMENT
Definitions
Quality
Risk
Degree to which a set
of inherent properties
of a product, system or process
fulfills requirements
combination of the
probabilityof occurrence of harm and
the severityof that harm
Systematic processfor the assessment,control, communication and review
of risks to the quality of the
drug (medicinal) product
across the product lifecycle
Management
QRM
ICH Q9
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ICH Q9 QUAL ITY RISK MANAGEMENT
Has QRM already been implemented?
Yes, however we need to firm-up and
set the priorities in relation to risks
We need to know> How good is our QRM compliance and decision making?
> To what extent QRM has to be implemented or formalised?
An then focus efforts and communicate in order to
> Avoid duplicationof effort and to align initiatives
> Develop scopeby using different viewpoints
e.g. from management, internal and external customers
CONSIDERATIONS
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ICH Q9 QUAL ITY RISK MANAGEMENT
Risk Management
Not a new concept ISO/IEC Guide 73: 2002 - Risk Management -
Vocabulary - Guidelines for use in Standards
ISO/IEC Guide 51:1999 - Safety Aspects-
Guideline for their inclusion in standards WHOTechnical Report Series No 908, 2003 Annex 7 Appl icat ion
of Hazard A nalysis and Cri t ical Contro l Point (HACCP)
methodo logy to pharmaceuticals
GAMP Good Practice Guide ISPE, 2005
A r isk-based approach to compl iant electronic records and
signatures
ISO 14971:2000 - Application of Risk Management
to Medical Devices
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ICH Q9 QUAL ITY RISK MANAGEMENT
Risk Review
RiskCommunication
Risk Assessment
Risk Evaluation
unacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
InitiateQuality Risk Management Process
Output / Result of the
Quality Risk Management Process
RiskManagementtoo
ls
ISO 14971 (medical devices) & ICH Q9
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ICH Q9 QUAL ITY RISK MANAGEMENT
Why we have ICH Q9?
To show how it can be applied by regulators and
industry to quality of pharmaceuticals (including API)
> We already do a lot of quality risk management
activities without identifying them as such
To enable manufacturing and regulatory flexibility
Provides the What? How? and Where? for
quality risk management
> Pharmaceutical development (ICH Q8) and Quality
Systems (ICH Q10) will facilitate the
What?, How? and Where?
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ICH Q9 QUAL ITY RISK MANAGEMENT
Quality Risk Management is NOT
Hiding risks
Writing half the truth (e.g. in an investigation report)
A means of removing industrys obligation to comply
with regulatory requirements
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ICH Q9 QUAL ITY RISK MANAGEMENT
Manage quality risks!
Quality management as function of time
Consequences
What ifdisaster happens?
Nowadays
QRM
Based on Prof. M. Haller, University St. Gallen, Switzerland
Using QRM
Prior use of QRM may
lower the consequences
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ICH Q9 QUAL ITY RISK MANAGEMENT
Implementing ICH Q9 means
The weakest chain will no longer be a problem
B k d
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ICH Q9 QUAL ITY RISK MANAGEMENT
Agenda
The ICH process
ICH Q9 and other ICH guidelines
From Risk to Quality Risk Management
Opportunities, Challenges and Benefit
B k d
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ICH Q9 QUAL ITY RISK MANAGEMENT
Integrate QRM during product life cycle
Say, what you do
Do, what you say
Gain experience
Improve it
Approval
Manufacture
for market
Analyse root cause:
Continuous
improvement
Update
documentation
Quality Risk
Management
(QRM)
(Risk of) Failure ?
B k d
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ICH Q9 QUAL ITY RISK MANAGEMENT
Risk Management & Flexibility
Definitions of Compliance:
> Conformity in fulfilling official requirements
> The act or process of complyingto a
desire, demand, or proposal or to coercion> A disposition to yield to others
> Theabilityof an object to yield elastically
when a force is applied: flexibility
Definition of Flexibility:
> characterised by a ready capability
to adaptto new,different, or changing requirementsSource: www.webster.com, 01. Nov.04
B k d
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ICH Q9 QUAL ITY RISK MANAGEMENT
QRM may help define acceptable quality levels
Not every single detailcan nor should be covered by
> Specifications (product quality)
> Documents (quality systems)
Set prioritiesand allocate resources
according to the potential for protection of patients
Use
science-based and
r isk-based behavior
B k d
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ICH Q9 QUAL ITY RISK MANAGEMENT
Opportunity for the Industry & Regulators
Using the same guidelineapply QRM to
> Industry (development, manufacture and distribution)
> Competent authorities (reviewer and inspectorate)
Facilitates common approachesto quality riskmanagement in our every day jobs
Supports science-baseddecision making
Focus resources basedon risks to patients Avoids restrictive and unnecessaryrequirements
Facilitates communication and transparency
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ICH Q9 QUAL ITY RISK MANAGEMENT
Conclusions for ICH Q9
Over all: Positive Contribution to patient protection
> Further develops Quality Risk Management awareness,
that is already part of industry and regulatory culture
Ongoing change in behaviour
> Identifying risks can be positive
> A long list of identified risks that are assessed and
controlled provides high quality capability
Awareness of quality risks
> Risk-basedapproach
> A potential of risks remains - No Zero risk!
Backgro nd
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ICH Q9 QUAL ITY RISK MANAGEMENT
Way Forward for Industry and Regulators
Improvecommunication and transparency
Adaptexisting
structures, organizations and systems
> Raise awareness of rationales fordecision making
> Develop trainingon methods and tools, as appropriate
> Do notcreatenew QRM organisations
> Do notcreatenew requirements
Adaptexisting requirements using quality risk
management behaviors
Background
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ICH Q9 QUAL ITY RISK MANAGEMENT
Opportunities & Benefits
Encourages transparency
> Create baseline for more science-based decisions
Facilitates communication
> Matrix team approach> An aid to convince the stakeholders with trust
Encourages a preventive approach
> Proactive control of risks and uncertainty
> Benefit of knowledge transfer by team approach Changes behavior
> Better understanding of risk-based decisions
> Acceptance of residual risks
Background
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ICH Q9 QUAL ITY RISK MANAGEMENT
Remember The use of Quality Risk Management is not mandatory
However, if you dont use it,
you will not gain the benefits
Background
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ICH Q9 QUAL ITY RISK MANAGEMENT
Change in behaviour
Sharing information
Background
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Background
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 55
ICH Q9 QUAL ITY RISK MANAGEMENT
Change in behaviour
From tick-box
approach for compliance
towards
systematicrisk-based thinking
Background
8/11/2019 02 Q9 Background
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Background
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 56
ICH Q9 QUAL ITY RISK MANAGEMENT
Change in behaviour
Doing things,
that do not matter
for the patient
Background
8/11/2019 02 Q9 Background
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BackgroundICH Q9 QUAL ITY RISK MANAGEMENT
Integration of QRM
into existing systems
andregulatory processes
will take time, trust andcommunication