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It supports setting and justifying acceptance criteria and selecting appropriate test procedures, including how specifications are defined as lists of tests, references to analytical procedures, and numerical limits or ranges. It explains the meaning of conformance to specifications and frames specifications as critical quality standards proposed by manufacturers and approved by regulatory authorities.",{"@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":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/ich-harmonised-tripartite-guideline-q6a-specifications-test-procedures-and-acceptance-criteria/390038/",{"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/ich-harmonised-tripartite-guideline-q6a-specifications-test-procedures-and-acceptance-criteria/390038.png","ImageObject",300,407,{"name":92,"@type":93},"Levi","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-09-25",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},"What is the main purpose of the ICH Q6A guideline?","Question",{"text":111,"@type":112},"To assist in establishing a single set of global specifications for new drug substances and new drug products by providing guidance on acceptance criteria and selection of test procedures.","Answer",{"name":114,"@type":109,"acceptedAnswer":115},"How does the guideline define a specification?",{"text":116,"@type":112},"A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria such as numerical limits, ranges, or other criteria.",{"name":118,"@type":109,"acceptedAnswer":119},"What does “conformance to specifications” mean?",{"text":120,"@type":112},"When tested using the listed analytical procedures, the drug substance and/or drug product will meet the specified acceptance criteria.","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},390038,1790329359,{"code":4,"msg":5,"data":130},{"doc_id":127,"user_id":131,"nickname":92,"user_avatar":132,"doc_module":4,"category_id":34,"category_name":35,"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":138,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":128,"read_time":143},7971461740909,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE  \nICH HARMONISED TRIPARTITE GUIDELINE  \nSPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS:  \nCHEMICAL SUBSTANCES  \nQ6A  \nCurrent Step 4 version  \ndated 6 October 1999  \nThis Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.  \nQ6A Document History  \n\n| First\u003Cbr>Codification | History | Date | New\u003Cbr>Codification\u003Cbr>November\u003Cbr>2005 |\n| --- | --- | --- | --- |\n| Q6A | Approval by the Steering Committee under Step 2 and release for public consultation. | 18\u003Cbr>July\u003Cbr>1997 | Q6A |\n\nCurrent Step 4 version  \n\n| Q6A | Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. | 6\u003Cbr>October\u003Cbr>1999 | Q6A |\n| --- | --- | --- | --- |\n\nSPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS:  \nCHEMICAL SUBSTANCES  \nICH Harmonised Tripartite Guideline  \nHaving reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 6 October 1999, this guideline is recommended for  \nadoption to the three regulatory parties to ICH  \nTABLE OF CONTENTS  \n1. INTRODUCTION................................................................................................... 1  \n1.1 Objective of the Guideline ........................................................................... 1  \n1.2 Background .................................................................................................. 1  \n1.3 Scope of the Guideline ................................................................................. 1  \n2. GENERAL CONCEPTS ........................................................................................ 2  \n2.1 Periodic or Skip Testing............................................................................... 2  \n2.2 Release vs. Shelf-life Acceptance Criteria................................................... 2  \n2.3 In-process Tests ........................................................................................... 3  \n2.4 Design and Development Considerations ................................................... 3  \n2.5 Limited Data Available at Filing................................................................. 3  \n2.6 Parametric Release ...................................................................................... 4  \n2.7 Alternative Procedures ................................................................................ 4  \n2.8 Pharmacopoeial Tests and Acceptance Criteria ......................................... 4  \n2.9 Evolving Technologies.................................................................................. 5  \n2.10 Impact of Drug Substance on Drug Product Specifications ....................... 5  \n2.11 Reference Standard...................................................................................... 5  \n3. GUIDELINES ......................................................................................................... 5  \n3.1 Specifications: Definition and Justification ................................................ 5  \n3.1.1 Definition of Specifications .......................................................... 5  \n3.1.2 Justification of Specifications ...................................................... 6  \n3.2 Universal Tests / Criteria............................................................................. 6  \n3.2.1 New Drug Substances ................................................................... 6  \n3.2.2 New Drug Products ....................................................................... 7  \n3.3 Specific Tests / Criteria ........","cbCailwichKDolXO","https://ap.wps.com/l/cbCailwichKDolXO","pdf",1328640,35,"English","# 1. Introduction\n## 1.1 Objective of the Guideline\n## 1.2 Background\n# 2. General Concepts\n## 2.1 Periodic or Skip Testing\n## 2.2 Release vs. Shelf-life Acceptance Criteria\n## 2.3 In-process Tests\n## 2.4 Design and Development Considerations\n## 2.5 Limited Data Available at Filing\n## 2.6 Parametric Release\n## 2.7 Alternative Procedures\n## 2.8 Pharmacopoeial Tests and Acceptance Criteria\n## 2.9 Evolving Technologies\n## 2.10 Impact of Drug Substance on Drug Product Specifications\n## 2.11 Reference Standard\n# 3. Guidelines\n## 3.1 Specifications: Definition and Justification\n## 3.1.1 Definition of Specifications\n## 3.1.2 Justification of Specifications\n## 3.2 Universal Tests / Criteria\n## 3.2.1 New Drug Substances\n## 3.2.2 New Drug Products\n## 3.3 Specific Tests / Criteria\n## 3.3.1 New Drug Substances\n## 3.3.2 New Drug Products\n# 4. Glossary\n# 5. References\n# 6. Attachments","[{\"question\":\"What is the main purpose of the ICH Q6A guideline?\",\"answer\":\"To assist in establishing a single set of global specifications for new drug substances and new drug products by providing guidance on acceptance criteria and selection of test procedures.\"},{\"question\":\"How does the guideline define a specification?\",\"answer\":\"A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria such as numerical limits, ranges, or other criteria.\"},{\"question\":\"What does “conformance to specifications” mean?\",\"answer\":\"When tested using the listed analytical procedures, the drug substance and/or drug product will meet the specified acceptance criteria.\"}]","ICH Harmonised Tripartite Guideline - Q6A - Specifications - Test Procedures and Acceptance Criteria | PDF",88]