QualityRiskManagementICHQ9Content.pptVIP

QualityRisk ManagementICH Q9Content Purpose of this part To guide through the content of the ICH Q9 document Provide some considerations, possible interpretations and where appropriate examples ICH Q9: Quality Risk Management (QRM) Document is available on the ICH Webpage Table of contents 1. Introduction 2. Scope 3. Principles of Quality Risk Management 4. General Quality Risk Management Process 5. Risk Management MethodologyAnnex I: Risk Management Methods and Tools 6. Integration of QRM process  into Industry and Regulatory operationsAnnex II: Potential Applications for QRM 7. Definitions 8. References 1. Introduction 2. Scope 2. Scope Drug substances, Drug (medicinal) products, Biological and biotechnological products Including the selection and use of Raw materials Solvents Excipients Packaging and labelling materials Components 3. Principles of Quality Risk Management Two primary principles: 4. General Quality Risk Management Process 4. A GeneralQuality Risk ManagementProcess 4. 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 approach 4. General Quality Risk Management Process Team approach Usually, but not always, undertaken by interdisciplinary teams from areas appropriate to the risk being considered e.g. Quality unit Development Engineering / Statistics Regulatory affairs Production operations Business, Sales and Marketing Legal Medical / Clinical … Individuals knowledgeable of the QRM processes 4. General Quality Risk Management Process 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 pertinent assumptions identifying the potential for risk Then assemble background information and/ or data on