This document provides an overview of quality risk management and the ICH Q9 guideline. It defines key terms like quality, risk, and risk management. The document outlines the quality risk management process, including risk identification, analysis, evaluation, control, and communication. It provides examples of how quality risk management can be applied to different aspects of drug development and manufacturing. The goal is to evaluate risks to quality based on scientific knowledge and link them to patient protection.

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2.  Purpose of QMS
 Introduction of QRM
 Meaning of risk
 Scope
 Principles
 Quality risk management process
 Risk management methods
 ICH Q9 guideline in new drug development
process
 Applications
 Conclusion
 Reference
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3. • To provide information on the
background of the ICH Q9
document.
• Give a aid by providing some
points of discussions on the
understanding of the quality risk
management concept.
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4. 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
• Quality is never-ending cycle of continuous
improvement
Risk
• Combination of the probability of occurrence of
harm and the severity of that harm
Manageme
nt
• Systematic process for the assessment,
control, communication and review of risks to
the quality of the drug product across the
product lifecycle

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7. • 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.
Including the selection and use of:-
 Raw Material
 Solvents
 Excipients
 Packaging and labelling materials 7

8. • Two primary principles of quality risk management
are:
The evaluation of the risk
to quality shouldbe based
on scientific
knowledgeand ultimately
link to theprotection of the
patient
Thelevel of
effort,formality and
documentation of the
quality risk management
process should
becommensurate with the
level of risk
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11. Risk identification
 Use of information to identify hazards or potential
risks
Historical data, theoretical analysis, informed
opinions
 Risk analysis is the estimation of risk associated with
identified hazards
Qualitative or quantitative
 Links probability and severity
Risk evaluation compares the identified and analyzed
risk against given risk criteria
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12.  Risk assessment consists of the identification of
hazards and the analysis and evaluation of risks
associated with exposure to those hazards.
 Risk control includes decision making to reduce
and / or accept risks.
• The purpose of risk control is to reduce the risk to
an acceptable level.
Risk communication is the sharing of information
about risk and risk management between the
decision makers and others.
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13. Hazards
Potential threat
- Chemical
reaction
- Manufacturing
issues
- Facilities and
equipment
System defect
- Not detected
- Insufficiently
prevented
- Emerges by
degree
Failure
- Technical
breakdown
- Human
breakdown
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14. Risk Management Methods
 Annex I
 Might be used in QRM by industry and regulators
 Situation in which a QRM procedure is used for
each of the tools
Short description & reference
 Strength and weaknesses
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15.  Annex ii
 Quality risk management as part of integrated
quality management documentation.
 Regulatory operations inspection and assessment
activities.
 Quality risk management as part of development
 Quality risk management for facilities, equipment
 Materials management
 Quality risk management as part of production.
 Laboratory control and stability studies.
 Packaging and labelling.
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LINK TO PATIENT RISK

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18. Applications
 Quality risk management as part of
 Integrated quality management
 Regulatory operations
 Industry operations
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19.  Q9 has broad risk concepts and principles
Principles for implementation
 Positive contribution to patient protection
 Awareness of quality risks conclusions for ICH
Q9
 Prevention is better than cure. Planning for
something that “MAY” happen, helps.
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20.  ICH Harmonised Tripartite Guideline, November
2005. Quality Risk Management Q9
 ICH Expert Working Group. Quality Risk
Management Q9. ICH Harmon
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