Date post: | 18-Dec-2014 |
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ICH GUIDELINE – Q9“QUALITY RISK MANAGEMENT”
PRESENTING BY,Ms.Sonali Diwate B.
M.Pharm (II Sem)
GUIDED BY,Prof. Shrivastav S.K.
MODERN C.O.P.,MOSHI, PUNE-412105
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AIM To Review and Study the ICH Guideline (Q9) QUALITY RISK MANAGEMENT
OBJECTIVES:
1. TO UNDERSTAND CONCEPT OF QRM
2. TO UNDERSTAND MEANING OF RISK
3. TO STUDY ROLE OF ICH Q9 GUIDELINE IN NEW DRUG DEVELOPMENT PROCESS
4. TO STUDY PRODUCT AND PROCESS RISK
5. TO STUDY RISK MNAGEMENT METHODOLOGY
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CONTENTS…..
1. AIM AND OBJECTIVE2.INTRODUCTION TO ICH GUIDELINES3.CONCEPT OF QRM4. MEANING OF RISK5.ICH Q9 GUIDELINE IN NEW DRUG DEVELOPMENT PROCESS6. PRODUCT AND PROCESS RISK7. RISK MNAGEMENT METHODOLOGY8. CONCLUSION9. REFERENCES
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ICH GUIDELINE• Q1 Stability• Q2 Analytical Validation• Q3 Impurities• Q4 Pharmacopoeias• Q5 Quality of Biotechnological Products• Q6 Specifications• Q7 Good Manufacturing Practice• Q8 Pharmaceutical Development• Q9 Quality Risk Management• Q10 Pharmaceutical Quality Systems
Different: - not a recipe- not a “SOP”
just a guidance
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Quality Risk Management ??????? A systematic process for the assessment, control,
communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle.
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Quality
Risk
Degree to which a set of inherent properties of a product, system or process fulfills requirements
combination of the probability of occurrence of harm and the severity of that harm
Systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle
Management
QRM
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• Risk is a cognitive and emotional response to expected loss.
• Risk is usually based on the expected value of the conditional
probability of the event occurring multiplied by the
consequences of the event given that it has occurred.
ACCORDING TO ICH GUIDELINE Q9
– Combination of the probability of occurrence of harm and the severity of that harm
Different meaning of Risk
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PRINCIPLES OF QUALITY RISK MANAGEMENT
• Two primary principles of quality risk management are:
The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient
The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk
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SCOPE OF QRM
• This guideline provides principles & examples of tools of quality risk management that can be applied to different aspects of pharmaceutical quality.
• These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological Products.
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Process
Materials
Design
Manufacturing
Distribution
Patient
Facilities
Opportunities to impact risk using quality risk
management
LINK TO PATIENT RISK
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Q10Q8
Process
Materials
Design
Manufacturing
Distribution
Patient
Facilities
Opportunities to impact risk using Quality Risk Management
Q9
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ResearchPreclinical
Phase Clinical Phases
Launch
QualityICH Q9
Safety
Efficacy
Manufacturing & Distribution
GLP
GCP
GMP
End of life cycle
ICH Q9 GUIDELINE IN NEW DRUG DEVELOPMENT PROCESS
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“Risk-based”Concepts and
Principles
Q8 Q9 Q10
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Pharmaceutical Development (Q8)
Past: Data transfer / Variable output
Present: Knowledge transfer / Science based 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 structuredprocess thinking
ChangedSituation
Q8
Q9 Q
10
15
Risk
from
Man
ufac
turin
g si
te
High
Low
HighLow
Using Q9 Quality Risk
Management principles
c
ontinual
impro
vem
ent
Q10
Pha
rm. Q
ualit
y Sy
stem
s
Q8 Pharmaceutical Development
Product and process risk
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?
Increasing external requirementsfor best practice, transparency and compliance• Public / Community• Governments• Regulators• Patients Investors /
Creditors
Growing complexityand scope of risks
• Globalisation “Multinational”
• Multi-factor approaches• Regulatory expectations • Acceptance of
risk and uncertainty
Increasing efforts and costs for sustainability
• Documentation• Projects• Systems• Interfaces
The HurdlesThe Hurdles
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Quality Risk
ManagementProactive disclosure
build trust and understanding
Improve communication
through sharing best practice and science
based knowledge
• An appropriate integrated approach helps to meet requirements more efficiently.
Master complexity Convert data into knowledge
e.g. by using methodology and tools
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Quality Risk Management Process
• Systematic processes designed to
coordinate, facilitate and improve science-based decision making with respect to risk to quality
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Risk Review
Ris
k C
om
mu
nica
tio
nRisk Assessment
Risk Evaluation
unacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
InitiateQuality Risk Management Process
Output / Result of theQuality Risk Management Process
Risk M
an
agem
en t to
ols
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Decision makers: Person(s) with competence and authority to make a decision
• Ensuring thatongoing Quality Risk Management processes operate
• Coordinating quality risk management process across various functions and departments
• Supportingthe team approach Risk Management Tools
High-level (Ideas and Concepts)Mid-Level (Quantitative and Qualitative)Low-Level (Real numbers and real time)
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When to initiate and plan a QRM Process???
• First define the question which should be answered (e.g. a problem and/or risk question)– including assumptions identifying the potential for risk
• Then assemble background information and/ or data on the potential hazard, harm or human health impact relevant to the risk– Identify a leader and necessary resources– Specify a timeline, deliverables and appropriate level of
decision making for the QRM process
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RISK MANAGEMENT METHODOLOGY • Quality risk management supports a scientific and practical approach to
decision-making.
• It provides documented, transparent and reproducible methods to accomplish
steps of the quality risk management process based on current knowledge
about assessing the probability, severity and sometimes detectability of the risk.
• Additionally, the pharmaceutical industry and regulators can assess and manage
risk using recognized risk management tools and/ or internal procedures (e.g.,
standard operating procedures).
1. Basic risk management facilitation methods (flowcharts, check sheets etc.)2. Failure Mode Effects Analysis (FMEA)3. Failure Mode, Effects and Criticality Analysis (FMECA)4. Fault Tree Analysis (FTA) 5. Hazard Analysis and Critical Control Points (HACCP)6. Hazard Operability Analysis (HAZOP)7. Preliminary Hazard Analysis (PHA)8. Risk ranking and filtering
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CONCLUSION• ICH Q9 explains
– A common language and process – Potential methodologies for QRM– Where QRM can add value
• Q9 has broad risk concepts and principles• Principles for implementation• Elements of Risk Assessment/Management Processes• Does not discuss a single tool, but “The Right Tool for the Job” approach
• A “cookbook” for risk management
• A specific prescription for your risk management program
• “The evaluation of the risk to quality should be based on scientific knowledge and ultimately link back to the protection of the patient; and
• The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk.”
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REFERENCE