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It serves as an important supplement to the JP, while not acting as general conformity standards except when drugs are approved under relevant product quality, efficacy, and safety legislation. It is organized into individually numbered categories, and each revision describes numbering rules, category updates, new preparations, revisions, and deletions, including quality assurance concepts for drug substances and products.",{"@graph":69,"@context":122},[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":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/basic-concepts-on-pharmaceutical-quality-general-information-revision-highlights/296772/",{"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/basic-concepts-on-pharmaceutical-quality-general-information-revision-highlights/296772.png","ImageObject",300,407,{"name":92,"@type":93},"Theodora","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-18",true,{"@type":102,"interactionType":103,"userInteractionCount":29},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is the role of General Information in relation to the JP?","Question",{"text":112,"@type":113},"It supplies reference information and reference test methods needed to ensure medicine quality, acting as an important supplement to the JP rather than serving as conformity standards, except under specified approval conditions.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How are General Information entries numbered?",{"text":117,"@type":113},"Each entry has three blocks: a category number, an in-category number, and right-block digits indicating the JP revision status (major revision or supplements/partial revision), with cross-citation shown in angle brackets.",{"name":119,"@type":110,"acceptedAnswer":120},"What changes does the volume report in its revision highlights?",{"text":121,"@type":113},"The revision covers numbering rule application, category reviews (including adding G0 and placing Others as GZ), newly prepared topics, revised methods and concepts, and at least one deleted item.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},296772,1789736597,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":29,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":129,"read_time":144,"preview_page_count":4},687197207919,"https://ap-avatar.wpscdn.com/avatar/a000253d6f5f7c60be?x-image-process=image/resize,m_fixed,w_180,h_180&k=1779446848396160552","General Information  \nGENERAL INFORMATION  \nThe General Information describes reference information and reference test methods necessary to assure the quality of medicines, which is attached to the JP. Therefore, the General Information is positioned as important information supplementing the JP although it should not be taken as indicating standards for conformity of drugs, except in the case specified when the drugs are granted approval based on the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. Combination use of the General Information and the JP can contribute to improve quality of the JP and user's convenience.  \nThe general information is classified into the following categories according to their contents, and each general information is individually numbered.  \nG0 . Basic Concepts on Pharmaceutical Quality G1 . Physics and Chemistry  \nG2 . Solid-state Properties  \nG3 . Biotechnological/Biological Products G4 . Microorganisms  \nG5 . Crude Drugs  \nG6 . Drug Formulation  \nG7 . Containers and Package G8 . Reference Standards GZ. Others  \nThe salient points of the revision in this volume are as follows:  \n1. Each general information was individually numbered according to the following rule.  \nAn individual number consists of three blocks. The left block indicates the category number and the central block indicates the number in the category. The figures in right block consist of the first two digits from the left indicating the JPat the recent revision (or new preparation, if not revised) and the third digit indicating as follows: 0 for major revision, 1 for supplement I, 2 for supplement II, and 3 for partial revision. For citation between the general information, the number corresponding to the general information is indicated in angle brackets \u003C > .  \n2. Categories were reviewed.  \n(1) As basic concepts on pharmaceutical quality, ``G0 Basic Concepts on Pharmaceutical Quality'' was newly added at the opening.  \n(2) ``Others'' was located at the end as ``GZ'', considering that any new categories would possibly be added after ``G9''.  \n(3) Water-related categories were abolished and included in ``GZ Others''.  \n3. The following were newly prepared.  \n(1) Basic Concept of the Quality Assurance on Biotechnological Products (Biopharmaceuticals) \u003CG3-1-180>  \n(2) Control of Culture Media and Strains of Microorganisms Used for Microbial Tests \u003CG4-2-180>  \n(3) Bacterial Endotoxins Test and Alternative Methods using Recombinant Protein-reagents for Endotoxin Assay \u003CG4-4-180>  \n(4) Radioactivity Measurements Method for Crude Drugs \u003CG5-8-180>  \n(5) Tablet Hardness Determinations \u003CG6-4-180>  \n(6) Packaging Integrity Evaluation of Sterile Products \u003CG7-4-180>  \n(7) Leak Tests for Packaging of Sterile Products \u003CG7-5-180>  \n4. The following were revised.  \n(1) Capillary Electrophoresis \u003CG3-7-180>  \n(2) On the Scientific Names of Crude Drugs listed in the JP \u003CG5-1-180>  \n(3) International Harmonization Implemented in the Japanese Pharmacopoeia Eighteenth Edition \u003CGZ-3-180>  \n5. The following was deleted.  \n(1) Control of Elemental Impurities in Drug Products  \nG0 Basic Concepts on Pharmaceutical Quality  \nBasic Concepts for Quality Assurance of Drug Substances and  \nDrug Products \u003CG0-1-172>  \nIntroduction  \nQuality of drug substances and products are generally assured through manufacturing and testing under appropriate Good Manufacturing Practice (GMP) conditions re‰ecting knowledge obtained from designing and developmental stages and manufacturing stage on management of raw materials and other materials, control of manufacturing process, speciˆcations, etc. As shown in the General Notice 5, JP listed drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude Drugs, General Rules for Preparations, and General Tests for their conformity to the Japanese Pharmacopoeia. In addition to these, compliance with GMP, managem","cbCaidrWe6H44Nff","https://ap.wps.com/l/cbCaidrWe6H44Nff","pdf",2723857,215,"English","# General Information\n## Structure and numbering rules\n## Revision highlights in this volume\n### Newly added categories and new preparations\n### Revised items\n### Deleted item\n## Basic concepts for quality assurance\n## Quality risk management and critical quality attributes","[{\"question\":\"What is the role of General Information in relation to the JP?\",\"answer\":\"It supplies reference information and reference test methods needed to ensure medicine quality, acting as an important supplement to the JP rather than serving as conformity standards, except under specified approval conditions.\"},{\"question\":\"How are General Information entries numbered?\",\"answer\":\"Each entry has three blocks: a category number, an in-category number, and right-block digits indicating the JP revision status (major revision or supplements/partial revision), with cross-citation shown in angle brackets.\"},{\"question\":\"What changes does the volume report in its revision highlights?\",\"answer\":\"The revision covers numbering rule application, category reviews (including adding G0 and placing Others as GZ), newly prepared topics, revised methods and concepts, and at least one deleted item.\"}]","Basic Concepts on Pharmaceutical Quality - General Information - Revision Highlights | PDF",542]