[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-665397-105":59,"doc-detail-665397-en":129},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":122,"head_meta":124,"extra_data":126,"updated_unix":128},105,"en","risk-assessment-for-compounding-ointments-quality-by-ishikawa-diagram-construction","RISK ASSESSMENT FOR COMPOUNDING OINTMENTS QUALITY BY ISHIKAWA DIAGRAM CONSTRUCTION","","Compounding medicines often do not undergo state registration, so ensuring their quality requires a structured pharmaceutical quality system incorporating risk assessment. This study maps quality risks of compounded ointments using an Ishikawa diagram and defines six major risk categories: personnel, API and excipients, equipment and facilities, preparation technology, stability, and quality control. Recommended monitoring factors and specific risk drivers are identified to support consistent product quality and reduce patient harm, and to enable transferability across countries with similar regulatory expectations.",{"@graph":69,"@context":121},[70,84,104],{"@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":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/risk-assessment-for-compounding-ointments-quality-by-ishikawa-diagram-construction/665397/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":98,"encodingFormat":97,"isAccessibleForFree":99,"interactionStatistic":100},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/risk-assessment-for-compounding-ointments-quality-by-ishikawa-diagram-construction/665397.png","ImageObject",300,407,{"name":92,"@type":93},"Supernature","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29",true,{"@type":101,"interactionType":102,"userInteractionCount":4},"InteractionCounter",{"@type":103},"ViewAction",{"@type":105,"mainEntity":106},"FAQPage",[107,113,117],{"name":108,"@type":109,"acceptedAnswer":110},"Why is a risk assessment process recommended for compounded ointments?","Question",{"text":111,"@type":112},"Because compounded medicines generally do not require state registration, a pharmaceutical quality system with risk assessment is needed to ensure their quality, safety, and effectiveness.","Answer",{"name":114,"@type":109,"acceptedAnswer":115},"How many major risk categories are defined in the study for ointment quality?",{"text":116,"@type":112},"Six major categories are defined: personnel; active pharmaceutical ingredients and excipients; equipment and facilities; preparation technology; stability; and quality control.",{"name":118,"@type":109,"acceptedAnswer":119},"What is the purpose of identifying monitoring factors and specific risk factors?",{"text":120,"@type":112},"Compliance and control of these factors enable pharmacies to produce ointments with appropriate quality and help prevent patient harm from administering dosage forms with lower quality.","https://schema.org",{"og:url":83,"og:type":123,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":125,"canonical":83},"index,follow",{"doc_id":127,"site_id":62},665397,1793302354,{"code":4,"msg":5,"data":130},{"doc_id":127,"user_id":131,"nickname":92,"user_avatar":132,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":133,"file_id":134,"file_url":135,"file_type":136,"file_size":137,"view_count":4,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":44,"language":138,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":139,"faqs":140,"seo_title":141,"seo_description":67,"update_tm":128,"read_time":142},962093270004,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","[https://doi.org/10.31925/farmacia.2021.4.8](https://doi.org/10.31925/farmacia.2021.4.8) ORIGINAL ARTICLE  \nRISK ASSESSMENT FOR COMPOUNDING OINTMENTS QUALITY BY ISHIKAWA DIAGRAM CONSTRUCTION  \nLESIA SAVCHENKO 1 *, YURI PIDPRUZHNYKOV 2, LIUDAS IVANAUSKAS 3, AUDRIUS LUKOŠIUS 4, VICTORIYA GEORGIYANTS 5  \n1Department of Quality, Standardization and Certification of Medicines, Institute of Pharmacy Professionals Qualification Improvement, National University of Pharmacy, 17 Zahysnynykiv Ukrainy Square, 61001, Kharkiv, Ukraine  \n2Department of Quality Management, National University of Pharmacy, 4 Valentynivska Street, 61000, Kharkiv, Ukraine  \n3Department of Analytical and Toxicological Chemistry, Lithuanian University of Health Sciences, 9 A. Mickevičiaus Street, 44307, Kaunas, Lithuania  \n4Department of Pharmacognosy, Lithuanian University of Health Sciences, 9 A. Mickevičiaus Street, 44307, Kaunas, Lithuania  \n5Department of Pharmaceutical Chemistry, National University of Pharmacy, 4 Valentynivska Street, 61000, Kharkiv, Ukraine  \n*corresponding author: [savchenkolesia@gmail.com](savchenkolesia@gmail.com)  \nManuscript received: November 2020  \nAbstract  \nTo date compounding medicines don’t need to pass the state registration process in any country. In order to ensure their quality, the introduction of a pharmaceutical quality system with risk assessment process is recommended in most countries worldwide. This research identifies the risks for quality of compounding ointments by Ishikawa diagram construction. Six major categories of risks (personnel; active pharmaceutical ingredients (API) and excipients; equipment and facilities; preparation technology; stability; quality control) were defined. Factors recommended to be monitored and specific risk factors for this dosage form quality were also identified. Their compliance and control will allow pharmacies to produce constantly ointments with appropriate quality and to prevent harm to the patient from administration of dosage forms with a lower quality. The similarity of the regulatory framework requirements for the preparation and quality control of the compounding ointments allows using the obtained results to ensure their quality in different countries.  \nRezumat  \nPână în prezent, medicamentele magistrale nu se supun înregistrării în nici o țară . De aceea se recomandă introducerea unuisistem de asigurare a calității și a unui proces de evaluare a riscurilor. Prezentul studiu identifică riscurile pentru calitatea unguentelor preparate în farmacie, cu ajutorul diagramei Ishikawa. Au fost definite șase categorii majore de riscuri (personal; ingrediente farmaceutice active și excipienți; echipamente și instalații; tehnologia de preparare; stabilitate; control alcalității) . Au fost identificați factorii ce se recomandă a fi monitorizați, alături de factorii de risc specifici, pentru această formă farmaceutică . Conformitatea și controlul acestora vor permite farmaciilor să producă în mod constant unguente cu ocalitate adecvată, care să prevină posibilele reacții în urma administrării unei forme dozate cu o calitate necorespunzătoare. Similitudinea cerințelor autorităților de reglementare pentru prepararea și controlul calității unguentelor permite utilizarea rezultatelor obținute în acest studiu pentru a asigura calitatea acestora în diferite țări.  \nKeywords: risk management, Ishikawa diagram, ointments, pharmaceutical compounding  \nIntroduction  \nOne of the differences between compounding preparations and industrially produced medicines is the absence of the marketing authorization for the first ones. However, this fact does not release them from the necessity to meet the established requirements for quality, efficiency, and safety. This issue is widely discussed in both Ukraine and the European Union (EU), and the USA [1-5, 16, 18-20] . Requirements for quality of pharmaceutical products in Ukraine are regulated, first, by the State Pharmacopoeia of Ukraine (SPhU) [11, 12], ","cbCaihNXY5TrdUN8","https://ap.wps.com/l/cbCaihNXY5TrdUN8","pdf",479771,"English","# Abstract\n# Introduction\n## Quality requirements for compounding medicines\n## Risk management within pharmaceutical quality systems\n# Methods\n## Ishikawa diagram construction for risk identification","[{\"question\":\"Why is a risk assessment process recommended for compounded ointments?\",\"answer\":\"Because compounded medicines generally do not require state registration, a pharmaceutical quality system with risk assessment is needed to ensure their quality, safety, and effectiveness.\"},{\"question\":\"How many major risk categories are defined in the study for ointment quality?\",\"answer\":\"Six major categories are defined: personnel; active pharmaceutical ingredients and excipients; equipment and facilities; preparation technology; stability; and quality control.\"},{\"question\":\"What is the purpose of identifying monitoring factors and specific risk factors?\",\"answer\":\"Compliance and control of these factors enable pharmacies to produce ointments with appropriate quality and help prevent patient harm from administering dosage forms with lower quality.\"}]","RISK ASSESSMENT FOR COMPOUNDING OINTMENTS QUALITY BY ISHIKAWA DIAGRAM CONSTRUCTION | PDF",23]