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