ICH Q9 QUALITY RISK MANAGEMENT Quality Risk …

1 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 1 ich q9 QUALITY RISK MANAGEMENTQ ualityQualityRisk ManagementRisk ManagementICH Q9 ich q9 ContentContentDisclaimer: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 by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 2 ich q9 QUALITY RISK MANAGEMENTP urpose of this part To guide through the contentof the ich q9 document Provide some considerations, possible interpretations and where appropriate examplesContentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 3 ich q9 QUALITY RISK MANAGEMENTICH Q9: QUALITY Risk MANAGEMENT (QRM) Document is available on the ICH by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 4 ich q9 QUALITY RISK MANAGEMENTT able of contents1.

2 Introduction2. Scope 3. Principles of QUALITY Risk MANAGEMENT 4. General QUALITY Risk MANAGEMENT Process5. Risk MANAGEMENT MethodologyAnnex I: Risk MANAGEMENT Methods and Tools6. Integration of QRM process into Industry and Regulatory operationsAnnex II: Potential Applications for QRM7. Definitions8. ReferencesContentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 5 ich q9 QUALITY RISK MANAGEMENT1. IntroductionRisk ManagementQuality Risk ManagementQuality SystemsHarmSeverityStakeholderProduct Life CycleGMP ComplianceContentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 6 ich q9 QUALITY RISK MANAGEMENTThis guideline provides principles & examples of tools of QUALITY risk MANAGEMENT that can beapplied to different aspects of pharmaceutical ScopeThese aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological productsICH Q9 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 7 ich q9 QUALITY RISK MANAGEMENT2.

3 Scope Drug substances, Drug (medicinal) products, Biological and biotechnological products Including the selection and use of >Raw materials>Solvents>Excipients>Packaging and labelling materials>ComponentsCONSIDERATIONSC ontentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 8 ich q9 QUALITY RISK MANAGEMENT3. Principles of QUALITY Risk ManagementTwo primary principles:The evaluation of the risk to QUALITY should be based on scientific knowledgeand ultimately link to the protection of the patientThe level of effort, formality and documentation of the QUALITY risk MANAGEMENT process should be commensurate with the level of riskICH Q9 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 9 ich q9 QUALITY RISK MANAGEMENT4. General QUALITY Risk MANAGEMENT Process Systematic processes designed to coordinate, facilitate and improve sciencescience--based decision makingbased decision makingwith respect to risk to qualityICH Q9 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 10 ich q9 QUALITY RISK MANAGEMENT4.

4 A GeneralQuality Risk ManagementProcess Team approachRisk ReviewRisk CommunicationRisk AssessmentRisk EvaluationunacceptableRisk ControlRisk AnalysisRisk ReductionRisk IdentificationReview EventsRisk AcceptanceInitiateQuality Risk MANAGEMENT ProcessOutput / Result of theQuality Risk MANAGEMENT ProcessRiskManagementtoolsICH Q9 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 11 ich q9 QUALITY RISK MANAGEMENT4. General QUALITY Risk MANAGEMENT Process 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 approachManagementresponsibilityICH Q9 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 12 ich q9 QUALITY RISK MANAGEMENT4.

5 General QUALITY Risk MANAGEMENT ProcessTeam approach Usually, but not always, undertaken by interdisciplinary teams from areas appropriate to the risk been considered > QUALITY unit>Development>Engineering / Statistics >Regulatory affairs>Production operations>Business, Sales and Marketing>Legal>Medical / Clinical>&.. Individuals knowledgeable of the QRM processesCONSIDERATIONSC ontentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 13 ich q9 QUALITY RISK MANAGEMENTRisk ReviewRi sk CommunicationRisk AssessmentRisk EvaluationunacceptableRisk ControlRisk AnalysisRisk ReductionRisk IdentificationReview EventsRisk AcceptanceInitiate QualityRisk MANAGEMENT ProcessOutput / Result of the QualityRisk MANAGEMENT ProcessRiskManage me nt t ools4. General QUALITY Risk MANAGEMENT Process When to initiate and plan a QRM Process Firstdefine the question which should be answered ( a problem and/or risk question)>including pertinent assumptions identifying the potential for risk Thenassemble 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 processICH Q9 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 14 ich q9 QUALITY RISK MANAGEMENTS hould risksbe assessed?

6 Are there clear rulesfor decision making? regulationsYes no RM Risk assessment not required(No flexibility)Follow procedures( Standard Operating Procedures)Document results,decisions and actionsWhen to apply QUALITY Risk MANAGEMENT ?CONSIDERATIONSB ased on K. Connelly, AstraZeneca, 20051. What might go wrong?2. What is the likelihood (probability)it will go wrong?3. What are the consequences (severity)?No orjustification neededCan you answerthe risk assessmentquestions?Yes informal RM Initiate Risk assessment(risk identification, analysis & evaluation)Run risk control(select appropriate measures)Agree on a team(small project)Select a Risk MANAGEMENT tool(if appropriate see ich q9 Annex I)No formal RM Carry out thequality risk MANAGEMENT processDocument the stepsContentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 15 ich q9 QUALITY RISK MANAGEMENTRisk ReviewRi sk CommunicationRisk AssessmentRisk EvaluationunacceptableRisk ControlRisk AnalysisRisk ReductionRisk IdentificationReview EventsRisk AcceptanceInitiate QualityRisk MANAGEMENT ProcessOutput / Result of the QualityRisk MANAGEMENT ProcessRiskManage me nt t ools4.

7 General QUALITY Risk MANAGEMENT Process Risk IdentificationWhat might go wrong? Risk AnalysisWhat is the likelihood (probability) it will go wrong? Risk EvaluationWhat are the consequences (severity)?Note: People often use terms Risk analysis , Risk assessment and Risk MANAGEMENT interchangeably which is incorrect!Risk Assessment3 fundamental questionsICH Q9 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 16 ich q9 QUALITY RISK MANAGEMENTRisk ReviewRi sk CommunicationRisk AssessmentRisk EvaluationunacceptableRisk ControlRisk AnalysisRisk ReductionRisk IdentificationReview EventsRisk AcceptanceInitiate QualityRisk MANAGEMENT ProcessOutput / Result of the QualityRisk MANAGEMENT ProcessRiskManage me nt t ools4. General QUALITY Risk MANAGEMENT Process What might go wrong? A systematic use of information to identify hazards referring to the risk question or problem>historical data>theoretical analysis>informed opinions>concerns of stakeholdersRisk Assessment: Risk IdentificationICH Q9 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 17 ich q9 QUALITY RISK MANAGEMENTRisk ReviewRi sk CommunicationRisk AssessmentRisk EvaluationunacceptableRisk ControlRisk AnalysisRisk ReductionRisk IdentificationReview EventsRisk AcceptanceInitiate QualityRisk MANAGEMENT ProcessOutput / Result of the QualityRisk MANAGEMENT ProcessRiskManage me nt t ools4.

8 General QUALITY Risk MANAGEMENT Process What is the likelihood it will go wrong? The estimation of the risk associated with the identified hazards. A qualitative or quantitative process of linking the likelihood of occurrence and severity of harm Consider detectability if applicable(used in some tools) Risk Assessment: Risk AnalysisICH Q9 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 18 ich q9 QUALITY RISK MANAGEMENT4. General QUALITY Risk MANAGEMENT ProcessRisk Assessment: Risk AnalysisOften data drivenKeep in mind: Statistical approached may or may not be used Maintain a robust data set! Start with the more extensive data set and reduce it Trend and use statistics ( extrapolation) Comparing between different sets requires compatible data Data must be reliable Data must be accessibleRisk ReviewRi sk CommunicationRisk AssessmentRisk EvaluationunacceptableRisk ControlRisk AnalysisRisk ReductionRisk IdentificationReview EventsRisk AcceptanceInitiate QualityRisk MANAGEMENT ProcessOutput / Result of the QualityRisk MANAGEMENT ProcessRisk Manage menttoolsCONSIDERATIONSC ontentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 19 ich q9 QUALITY RISK MANAGEMENTRisk ReviewRi sk CommunicationRisk AssessmentRisk EvaluationunacceptableRisk ControlRisk AnalysisRisk ReductionRisk IdentificationReview EventsRisk AcceptanceInitiate QualityRisk MANAGEMENT ProcessOutput / Result of the QualityRisk MANAGEMENT ProcessRiskManage me nt t ools4.

9 General QUALITY Risk MANAGEMENT Process What is the risk? Compare the identified and analysed riskagainst given risk criteria Consider the strength of evidence for all three of the fundamental questions> What might go wrong?> What is the likelihood (probability) it will go wrong?> What are the consequences (severity)?Risk Assessment: Risk EvaluationContentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 20 ich q9 QUALITY RISK MANAGEMENT4. General QUALITY Risk MANAGEMENT ProcessRisk Assessment: Risk EvaluationA picture of the life cycleProbabilityDetectabilitySeveritypas ttodayfutureData refers totimeImpactCan you find it?= Risk Priority Numberxx Frequency of occurences driven by the number of trials Degree of beliefCONSIDERATIONSC ontentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 21 ich q9 QUALITY RISK MANAGEMENTRisk ReviewRi sk CommunicationRisk AssessmentRisk EvaluationunacceptableRisk ControlRisk AnalysisRisk ReductionRisk IdentificationReview EventsRisk AcceptanceInitiate QualityRisk MANAGEMENT ProcessOutput / Result of the QualityRisk MANAGEMENT ProcessRiskManage me nt t ools4.

10 General QUALITY Risk MANAGEMENT Process Risk Control: Decision-making activity Is the risk above an acceptable level? What can be done to reduce or eliminaterisks? What is the appropriate balancebetween benefits, risks and resources? Are new risks introduced as a result of the identified risks being controlled? ich q9 Contentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 22 ich q9 QUALITY RISK MANAGEMENT4. General QUALITY Risk MANAGEMENT ProcessRisk Control: Residual Risk The residual risk consists of > Hazards that have been assessed and risks that have been accepted> Hazards which have been identified but the risks have not been correctly assessed> Hazards that have not yet been identified> Hazards which are not yet linked to the patient risk Is the risk reduced to an acceptable level?> Fulfil all legal and internal obligations> Consider current scientific knowledge & techniquesRisk ReviewRi sk CommunicationRisk AssessmentRisk EvaluationunacceptableRisk ControlRisk AnalysisRisk ReductionRisk IdentificationReview EventsRisk AcceptanceInitiate QualityRisk MANAGEMENT ProcessOutput / Result of the QualityRisk MANAGEMENT ProcessRisk Manage menttoolsCONSIDERATIONSC ontentprepared by some members of the ich q9 EWG for example only; not an official policy/guidanceJuly 2006, slide 23 ich q9 QUALITY RISK MANAGEMENTRisk ReviewRi sk CommunicationRisk AssessmentRisk EvaluationunacceptableRisk ControlRisk AnalysisRisk ReductionRisk IdentificationReview EventsRisk AcceptanceInitiate QualityRisk MANAGEMENT ProcessOutput / Result of the QualityRisk MANAGEMENT ProcessRiskManage me nt t ools4.