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It explains why effective control reduces hazards when manufacturing or regulatory activities are less effective, and how risk assessment and recognition of hazards enable improved regulatory control within available resources. The annex covers QRM principles, glossary, the QRM process (initiation, assessment, control, review, verification, communication, documentation), tools, and specific applications for pharmaceuticals and medicines regulatory authorities including inspection, dossier review, and manufacturing-site assessment.",{"@graph":69,"@context":126},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/annex-2-who-guidelines-on-quality-risk-management/665396/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/annex-2-who-guidelines-on-quality-risk-management/665396.png","ImageObject",300,407,{"name":92,"@type":93},"How to eat","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-10-29",true,{"@type":102,"interactionType":103,"userInteractionCount":14},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118,122],{"name":109,"@type":110,"acceptedAnswer":111},"What problem does WHO quality risk management (QRM) guidance address?","Question",{"text":112,"@type":113},"It addresses the patient risk that can arise when control of medicine quality is less effective, leading to medicines of inadequate quality. The guidance supports improved regulatory control by assessing risks and recognizing hazards at key stages of production and distribution.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What is the overall definition of QRM in the guidelines?",{"text":117,"@type":113},"QRM is an overall and continuing process of appropriately managing risks to product quality throughout the product’s life-cycle to optimize the benefit–risk balance. It is systematic and applies through assessment, control, communication, and review, both proactively and retrospectively.",{"name":119,"@type":110,"acceptedAnswer":120},"How is QRM applied for medicines regulatory authorities?",{"text":121,"@type":113},"The annex describes QRM considerations for inspection strategy, including how risk management informs inspection planning and conduct. It also covers corrective action and preventive action review and scheduling of routine inspections, complaint handling and investigation, and applying QRM to dossier review.",{"name":123,"@type":110,"acceptedAnswer":124},"Which lifecycle activities are included in the aim of these QRM guidelines?",{"text":125,"@type":113},"The aim is to assist development and implementation of effective QRM across research and development, sourcing of materials, manufacturing, packaging, testing, storage, and distribution.","https://schema.org",{"og:url":83,"og:type":128,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":130,"canonical":83},"index,follow",{"doc_id":132,"site_id":62},665396,1793302353,{"code":4,"msg":5,"data":135},{"doc_id":132,"user_id":136,"nickname":92,"user_avatar":137,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":138,"file_id":139,"file_url":140,"file_type":141,"file_size":142,"view_count":14,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":143,"language":144,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":145,"faqs":146,"seo_title":147,"seo_description":67,"update_tm":133,"read_time":148},962093541613,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","Annex 2  \nWHO guidelines on quality risk management  \n1. Introduction 62  \n1.1 Background and scope 62  \n1.2 Principles of quality risk management 64  \n2. Glossary 67  \n3. Quality risk management process 70  \n3.1 Initiating a QRM process 70  \n3.2 Personnel involved in QRM 70  \n3.3 Knowledge of the product and process 71  \n3.4 Risk assessment 71  \n3.5 Risk control 72  \n3.6 Risk review 73  \n3.7 Verification of QRM process and methodologies 74  \n3.8 Risk communication and documentation 75  \n4. QRM application for pharmaceuticals 76  \n4.1 Training and education 76  \n4.2 Responsibilities 76  \n4.3 QRM application during product development 77  \n4.4 QRM application during validation and qualification 78  \n4.5 QRM application during commercial manufacturing 79  \n4.5.1 QRM integration with key quality system elements 79  \n4.5.2 QRM application in product manufacturing operations 80  \n5. QRM considerations for medicines regulatory authorities 81  \n5.1 Introduction 81  \n5.2 QRM application to inspection strategy 82  \n5.2.1 Risk management in inspections 82  \n5.2.2 Inspection planning and conduct 82  \n5.2.3 Corrective action and preventive action review, and scheduling of routine inspections 83  \n5.2.4 Complaint handling and investigation 83  \n5.3 Inspection of QRM at a manufacturing site 83  \n5.4 QRM applied to dossier review (assessment) 85  \n6. Risk management tools 87  \nReferences 91  \n61  \n62  \nWHO Technical Report Series No. 98 1, 2013  \n1. Introduction  \n1.1 Background and scope  \nIn most countries compliance with good manufacturing practices (GMP)( 1, 2) (including validation), medicines regulatory activities and inspections, together with supply chain controls throughout the product life-cycle, provide good assurance that risks are largely controlled. However, where control is less effective, patients may be put at risk through the production of medicines of inadequate quality. The assessment of individual risks related to specific products and starting materials and the recognition of hazards at specific stages of production or distribution should permit regulatory authorities to improve control of medicines by increasing the effectiveness of their activities within the limits of the available resources. Quality risk management (QRM) is a process that is relevant to all countries and should provide a rationale to understand risk and mitigate it through appropriate and robust controls.  \nThe aim of these guidelines is to assist the development and implementation of effective QRM, covering activities such as research and development, sourcing of materials, manufacturing, packaging, testing, storage and distribution. In the past, hazard analysis and critical control point (HACCP) methodology, traditionally a food safety management system but subsequently applied to other industries, has been the basis of WHO risk management guidance to the pharmaceutical industry (3) .  \nMore recently international guidance has emerged (2, 4–7) that is of specific relevance to the pharmaceutical industry and which addresses the full scope of pharmaceutical industry QRM more effectively than HACCP principles, including how to structure regulatory filings using a risk-based approach. Consequently, these WHO guidelines have been developed as an update on WHO's advice to the pharmaceutical industry, taking account of this new guidance.  \nTo protect patients in terms of quality, safety and efficacy of medicines, international medicines regulatory authorities (MRAs) are recommending pharmaceutical manufacturers to adopt a risk-based approach to the life-cycle of a pharmaceutical product. Some MRAs require the adoption of a risk-based approach for specific areas in the life-cycle of a pharmaceutical product, e.g. environmental monitoring in sterile products manufacture. The level of QRM activity and the density of associated documentation will evolve as the product progresses from early development through to routine production.  \nQRM is the overall and con","cbCaimVwgyl2UJMR","https://ap.wps.com/l/cbCaimVwgyl2UJMR","pdf",234622,32,"English","# Introduction\n## Background and scope\n## Principles of quality risk management\n# Glossary\n# Quality risk management process\n## Initiating a QRM process\n## Personnel involved in QRM\n## Risk assessment\n## Risk control\n## Risk review\n## Verification of QRM process and methodologies\n## Risk communication and documentation\n# QRM application for pharmaceuticals\n## Training and education\n## Responsibilities\n## QRM application during product development\n## QRM application during validation and qualification\n## QRM application during commercial manufacturing\n## QRM integration with key quality system elements\n## QRM application in product manufacturing operations\n# QRM considerations for medicines regulatory authorities\n## Introduction\n## QRM application to inspection strategy\n## Inspection of QRM at a manufacturing site\n## QRM applied to dossier review (assessment)\n# Risk management tools\n# References","[{\"question\":\"What problem does WHO quality risk management (QRM) guidance address?\",\"answer\":\"It addresses the patient risk that can arise when control of medicine quality is less effective, leading to medicines of inadequate quality. The guidance supports improved regulatory control by assessing risks and recognizing hazards at key stages of production and distribution.\"},{\"question\":\"What is the overall definition of QRM in the guidelines?\",\"answer\":\"QRM is an overall and continuing process of appropriately managing risks to product quality throughout the product’s life-cycle to optimize the benefit–risk balance. It is systematic and applies through assessment, control, communication, and review, both proactively and retrospectively.\"},{\"question\":\"How is QRM applied for medicines regulatory authorities?\",\"answer\":\"The annex describes QRM considerations for inspection strategy, including how risk management informs inspection planning and conduct. It also covers corrective action and preventive action review and scheduling of routine inspections, complaint handling and investigation, and applying QRM to dossier review.\"},{\"question\":\"Which lifecycle activities are included in the aim of these QRM guidelines?\",\"answer\":\"The aim is to assist development and implementation of effective QRM across research and development, sourcing of materials, manufacturing, packaging, testing, storage, and distribution.\"}]","Annex 2 - WHO guidelines on quality risk management | PDF",81]