[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-40327-en":3,"doc-seo-40327-105":30,"detail-sidebar-cat-0-en-105":91},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":4,"category_id":11,"category_name":12,"doc_title":13,"doc_description":14,"doc_content":15,"file_id":16,"file_url":17,"file_type":18,"file_size":19,"view_count":20,"is_deleted":4,"is_public":21,"is_downloadable":21,"audit_status":21,"page_count":22,"language":23,"language_code":24,"site_id":25,"html_lang":24,"table_of_contents":26,"faqs":27,"seo_title":13,"seo_description":14,"update_tm":28,"read_time":29},40327,2336464648322,"Aria","https://ap-avatar.wpscdn.com/avatar/2200025388227c56fec?_k=1778556882303663488",7,"Healthcare","Quality Assurance of Pharmaceuticals Volume 2 Good Manufacturing Practices and Inspection","Quality assurance of pharmaceuticals—Volume 2 (2nd updated edition) consolidates WHO guidance for ensuring pharmaceutical product quality through good manufacturing practices and effective inspection systems. The volume covers core manufacturing principles and quality management, requirements for starting materials and specific product categories, and inspection activities across pre-approval, manufacturers, and distribution channels. It also includes model documentation and tools supporting hazard and risk analysis, validation, sampling, and herbal medicine manufacturing practices.","QAPPR  \n12/16/06  \n12:10  \nPM  \nPage i  \nQuality assurance of pharmaceuticals  \nA compendium of guidelines and related materials  \nVolume 2, 2nd updated edition  \nGood manufacturing practicesand inspection  \nQAPPR  \n12/16/06  \n12:10 PM Page ii  \nWHO Library Cataloguing-in-Publication Data  \nQuality assurance of pharmaceuticals : a compendium of guidelines and related materials. Vol. 2, Good manufacturing practices and inspection.– 2nd ed.  \n1. Drug and narcotic control – standards 2 . Drug industry – standards  \n3. Pharmaceutical preparations – standards 4 . Biological products – standards  \n5.Quality control 6 . Guidelines I.World Health Organization  \nII.Title: Good manufacturing practices and inspection  \nISBN 92 4 154708 1 (NLM classification: QV 33) ISBN 978 92 4 154708 6  \n© World Health Organization 2007  \nAll rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel. : +41 22 791 3264; fax: +41 22 791 4857; e-mail: [bookorders@who.int](bookorders@who.int)) . Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [permissions@who.int](permissions@who.int)) .  \nThe designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.  \nThe mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.  \nAll reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.  \nPrinted in India  \nQAPPR  \n12/16/06  \n12:10 PM Page iii  \nContents  \nIntroduction 1  \n1. WHO good manufacturing practices: main principles for  \npharmaceutical products 7  \nQuality management in the drug industry: philosophy and essential elements (update on sampling) (new) 7  \nHeating Ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (new) 58  \nValidation (new) 101  \nWater for pharmaceutical use (new) 170  \n2. WHO good manufacturing practices: starting materials 188 Active pharmaceutical ingredients (bulk drug substances) 188 Pharmaceutical excipients 196  \n3. WHO good manufacturing practices: specific  \npharmaceutical products 215  \nSterile pharmaceutical products 215  \nBiological products 232  \nInvestigational pharmaceutical products for clinical trials in humans 242  \nThe manufacture of herbal medicines (updated) 254  \nRadiopharmaceutical products 276  \n4. Inspection 285  \nPre-approval inspections 285  \nInspection of pharmaceutical manufacturers 291  \nInspection of drug distribution channels 303  \nQuality systems requirements for national good  \nmanufacturing practice inspectorates 322  \nGuidance on good manufacturing practices:  \ninspection report 338  \nModel certificate of good manufacturing practices 347  \niii  \nQUALITY ASSURANCE OF PHARMACEUTICALS  \n5. Hazard and risk analysis in pharmaceutical products 346  \nApplication of hazard analysis and critical control point (HACCP) method","cbCaiozE0Bzr70Dy","https://ap.wps.com/l/cbCaiozE0Bzr70Dy","pdf",4816233,3,1,416,"English","en",105,"# Introduction\n# WHO good manufacturing practices: main principles for pharmaceutical products\n## Quality management in the drug industry\n## Heating Ventilation and air-conditioning systems for non-sterile dosage forms\n## Validation\n## Water for pharmaceutical use\n# WHO good manufacturing practices: starting materials\n## Active pharmaceutical ingredients\n## Pharmaceutical excipients\n# WHO good manufacturing practices: specific pharmaceutical products\n## Sterile pharmaceutical products\n## Biological products\n## Investigational pharmaceutical products\n## The manufacture of herbal medicines\n## Radiopharmaceutical products\n# Inspection\n## Pre-approval inspections\n## Inspection of pharmaceutical manufacturers\n## Inspection of drug distribution channels\n## Quality systems requirements for national inspectorates\n## Inspection report and model certificate\n# Hazard and risk analysis in pharmaceutical products\n## HACCP methodology for pharmaceuticals\n# Sampling operations\n## Sampling of pharmaceutical products and related materials","[{\"question\":\"What is covered in Volume 2 of WHO quality assurance of pharmaceuticals?\",\"answer\":\"Volume 2 compiles WHO guidance on good manufacturing practices and inspection, including principles for quality management, validation, water for pharmaceutical use, starting materials, specific product categories, and inspection activities.\"},{\"question\":\"How does the document address manufacturing of herbal medicines?\",\"answer\":\"It includes a dedicated section on the manufacture of herbal medicines, updated, as part of the good manufacturing practices for specific pharmaceutical products.\"},{\"question\":\"What roles do hazard and risk analysis and sampling play in quality assurance?\",\"answer\":\"The volume provides guidance on applying hazard analysis and HACCP methodology to pharmaceuticals, and includes sampling operations for pharmaceutical products and related materials to support reliable quality 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