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Annex 1 focuses on the manufacture of sterile medicinal products, covering scope and core principles, Pharmaceutical Quality System elements, premises and barrier technologies, qualification of cleanrooms and clean air equipment, and controls for disinfection, utilities, water, steam, and gas systems. It further addresses sterile production technologies including aseptic preparation, filtration, FFS and blow-fill-seal, lyophilization, closed and single-use systems, environmental/process monitoring, aseptic process simulation, and quality control, plus supporting definitions.",{"@graph":14,"@context":65},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/guide-to-good-manufacturing-practice-for-medicinal-products-annexes-annex-1-manufacture-of-sterile-medicinal-products/267744/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/guide-to-good-manufacturing-practice-for-medicinal-products-annexes-annex-1-manufacture-of-sterile-medicinal-products/267744.png","ImageObject",300,407,{"name":42,"@type":43},"Ava Thompson","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-23","2026-09-14",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",21,{"@type":57,"mainEntity":58},"FAQPage",[59],{"name":60,"@type":61,"acceptedAnswer":62},"How does Annex 1 address control and verification of aseptic processes?","Question",{"text":63,"@type":64},"It includes environmental and process monitoring (particle counts and viable particles), aseptic process simulation (media fill), general environmental monitoring items, and links to quality control elements and definitions via the annex structure.","Answer","https://schema.org",{"og:url":32,"og:type":67,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":69,"canonical":32},"index,follow",{"doc_id":71,"site_id":7},267744,1789424612,{"code":4,"msg":74,"data":75},"success",[76,80,84,88,93,98,102,107,112,115,119],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":77,"show_sort_weight":78,"slug":79},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":81,"show_sort_weight":82,"slug":83},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Exam",70,"exam",{"id":89,"doc_module":4,"doc_module_name":25,"category_name":90,"show_sort_weight":91,"slug":92},5,"Comic",60,"comic",{"id":94,"doc_module":4,"doc_module_name":25,"category_name":95,"show_sort_weight":96,"slug":97},6,"Technology",50,"technology",{"id":99,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":100,"slug":101},7,40,"healthcare",{"id":103,"doc_module":4,"doc_module_name":25,"category_name":104,"show_sort_weight":105,"slug":106},8,"Research & Report",30,"research-report",{"id":108,"doc_module":4,"doc_module_name":25,"category_name":109,"show_sort_weight":110,"slug":111},9,"Religion & Spirituality",20,"religion-spirituality",{"id":110,"doc_module":4,"doc_module_name":25,"category_name":113,"show_sort_weight":110,"slug":114},"World Cup","world-cup",{"id":116,"doc_module":4,"doc_module_name":25,"category_name":117,"show_sort_weight":116,"slug":118},10,"Lifestyle","lifestyle",{"id":120,"doc_module":4,"doc_module_name":25,"category_name":121,"show_sort_weight":89,"slug":122},19,"General","general",{"code":4,"msg":74,"data":124},{"doc_id":71,"user_id":125,"nickname":42,"user_avatar":126,"doc_module":4,"category_id":99,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":127,"file_id":128,"file_url":129,"file_type":130,"file_size":131,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":132,"language":133,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":134,"faqs":135,"seo_title":136,"seo_description":12,"update_tm":72,"read_time":137},1649267921044,"https://us-avatar.wpscdn.com/avatar/1800007509477c92dfb?_k=1786009248482753345","PE 009-17 (Annexes)  \n25 August 2023  \nGUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS  \nANNEXES  \n© PIC/S 2023  \nReproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged.  \nEditor: PIC/S Secretariat  \n14 rue du Roveray CH-1207 Geneva  \ne-mail:  [info@picscheme.org](info@picscheme.org)  \nweb site:  [https://www.picscheme.org](https://www.picscheme.org)  \nANNEXES  \nAnnex 1 (Manufacture of sterile medicinal products) 1  \nDocument map 1  \nScope 2  \nPrinciple 2  \nPharmaceutical Quality System (PQS) 5  \nPremises 6  \nBarrier technologies 9  \nCleanroom and clean air equipment qualification 12  \nDisinfection 15  \nEquipment 16  \nUtilities 17  \nWater systems 18  \nSteam used as a direct sterilising agent 19  \nGases and vacuum systems 20  \nHeating and cooling and hydraulic systems 20  \nPersonnel 20  \nProduction and specific technologies 24  \nTerminally sterilised products 24  \nAseptic preparation and processing 24  \nFinishing of sterile products 27  \nSterilisation 29  \nSterilisation by heat 32  \nMoist heat sterilisation 32  \nDry heat sterilisation 34  \nSterilisation by radiation 35  \nSterilisation with ethylene oxide 35  \nFilter sterilisation of products which cannot be sterilised in their final container 36  \nForm-Fill-Seal (FFS) 40  \nBlow-Fill-Seal 42  \nLyophilization 45  \nClosed systems 46  \nSingle Use Systems (SUS) 47  \nEnvironmental and process monitoring 48  \nGeneral 48  \nEnvironmental and process monitoring 49  \nEnvironmental monitoring – total particle 50  \nEnvironmental and personnel monitoring – viable particle 52  \nAseptic process simulation (APS) (also known as media fill) 54 Quality control (QC) 59  \nGlossary 61  \nAnnex 2A  \n(Manufacture of advanced therapy medicinal products for human use) 68  \nScope 68  \nPrinciple 72  \nPart A: General guidance 73  \nSupplimentary provisions to PIC/S GMP Guide Part I 74  \nChapter 1 Pharmaceutical quality system 74  \nChapter 2 Personnel 74  \nChapter 3 Premises and equipment 75  \nChapter 4 Documentation 79  \nChapter 5 Production 80  \nChapter 6 Quality control 91  \nChapter 7 Outsourced activities 96  \nChapter 8 Complaints and product recall 97  \nPart B: Specific guidance on selected product types 98  \nCommon glossary to Annex 2A and 2B 101  \nAnnex 2B  \n(Manufacture of biological medicinal substances and products for human use) 108  \nScope 109  \nPrinciple 110  \nPart A: General guidance 112  \nPersonnel 112  \nPremises and equipment 112  \nAnimals 115  \nDocumentation 116  \nProduction 116  \nStarting and raw materials 117  \nSeed lot and cell bank system 119  \nOperating principles 120  \nQuality control 122  \nPart B: Specific guidance on selected product types 123  \nAnnex 3 (Manufacture of radiopharmaceuticals) 128  \nPrinciple 128  \nIntroduction 128  \nQuality assurance 129  \nPersonnel 130  \nPremises and equipment 130  \nDocumentation 131  \nProduction 131  \nQuality control 132  \nReference and retention samples 134  \nDistribution 134  \nGlossary 134  \nAnnex 4  \n(Manufacture of veterinary medicinal products other than immunologicals) 135  \nManufacture of premixes for medicated feeding stuffs 135  \nThe manufacture of ectoparasiticides 136  \nThe manufacture of veterinary medicinal products containing penicillins 136  \nRetention of samples 136  \nSterile veterinary medicinal products 136  \nAnnex 5 (Manufacture of immunological veterinary medical products) 137  \nPrinciple 137  \nPersonnel 137  \nPremises 138  \nEquipment 141  \nAnimals and animal houses 142  \nDisinfection Waste disposal 142  \nProduction 143  \nStarting materials 143  \nQuality control 146  \nAnnex 6 (Manufacture of medicinal gases) 147  \nPrinciple 147  \nManufacture of active substance gases 147  \nManufacture of medicinal gases 148  \nPersonnel 148  \nPremises and equipment 149  \nDocumentation 150  \nProduction 151  \nQuality control 154  \nTransportation of packaged gases 155  \nGlossary 156  \nAnnex 7 (Manufacture of herbal medicinal products) 158  \nPrinciple 158  \nPremis","cbCaivRs3QKZLnnI","https://ap.wps.com/l/cbCaivRs3QKZLnnI","pdf",2368402,284,"English","# Annexes\n## Annex 1 (Manufacture of sterile medicinal products)\n## Annex 2A (Manufacture of advanced therapy medicinal products for human use)\n## Annex 2B (Manufacture of biological medicinal substances and products for human use)\n## Annex 3 (Manufacture of radiopharmaceuticals)\n## Annex 4 (Manufacture of veterinary medicinal products other than immunologicals)\n## Annex 5 (Manufacture of immunological veterinary medical products)\n## Annex 6 (Manufacture of medicinal gases)\n## Annex 7 (Manufacture of herbal medicinal products)\n## Annex 8 (Sampling of starting and packaging materials)\n## Annex 9 (Manufacture of liquids, creams and ointments)\n## Annex 10 (Manufacture of pressurised metered dose aerosol preparations for inhalation)\n## Annex 11 (Computerised systems)\n## Annex 12 (Use of ionising radiation in the manufacture of medicinal products)\n## Annex 13 (Manufacture of investigational medicinal products)\n## Annex 14 (Manufacture of medicinal products derived from human blood or plasma)","[{\"question\":\"How does Annex 1 address control and verification of aseptic processes?\",\"answer\":\"It includes environmental and process monitoring (particle counts and viable particles), aseptic process simulation (media fill), general environmental monitoring items, and links to quality control elements and definitions via the annex structure.\"}]","GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS - ANNEXES - Annex 1 - Manufacture of sterile medicinal products | PDF",716]