[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-289742-105":3,"detail-sidebar-cat-0-en-105":81,"doc-detail-289742-en":130},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","process-analytical-technologies-pat-and-quality-by-design-the-impact-for-process-systems-engineering","Process Analytical Technologies (PAT) and Quality by Design - The Impact for Process Systems Engineering","","Presentation content on Process Analytical Technologies (PAT) and Quality by Design (QbD) explores how these frameworks influence process systems engineering, with emphasis on pharmaceutical-sector challenges. It surveys the evolution of PAT and the directions ahead, discusses difficulties in spectroscopic data pre-processing and modelling, and highlights applications in crystallisation and other industrial problems. The material addresses variability across formulations, production units, sites, and probe locations, and explains closing the analytical control loop. 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It also highlights issues tied to spectroscopic data modelling and operational variability across manufacturing contexts.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"How does the presentation connect variability to PAT and QbD?",{"text":68,"@type":64},"Variability is linked to different product formulations, recipes, processing units, production sites, and spectroscopic probe locations. It also notes that heterogeneity can be influenced by the manufacturing process and upstream/downstream changes.",{"name":70,"@type":61,"acceptedAnswer":71},"What KPI benchmarks are used to compare pharmaceutical manufacturing performance?",{"text":72,"@type":64},"Benchmarks include Stock Turn, OTIF (On Time in Full), RFT (Right First Time), CpK (process variability measure), and OEE (Overall Equipment Effectiveness). The document defines each metric and contrasts performance across plant categories.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},289742,1789636815,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,111,114,119,122,126],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":97,"doc_module":4,"doc_module_name":25,"category_name":98,"show_sort_weight":99,"slug":100},5,"Comic",60,"comic",{"id":102,"doc_module":4,"doc_module_name":25,"category_name":103,"show_sort_weight":104,"slug":105},6,"Technology",50,"technology",{"id":107,"doc_module":4,"doc_module_name":25,"category_name":108,"show_sort_weight":109,"slug":110},7,"Healthcare",40,"healthcare",{"id":55,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":112,"slug":113},30,"research-report",{"id":115,"doc_module":4,"doc_module_name":25,"category_name":116,"show_sort_weight":117,"slug":118},9,"Religion & Spirituality",20,"religion-spirituality",{"id":117,"doc_module":4,"doc_module_name":25,"category_name":120,"show_sort_weight":117,"slug":121},"World Cup","world-cup",{"id":123,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":123,"slug":125},10,"Lifestyle","lifestyle",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":97,"slug":129},19,"General","general",{"code":4,"msg":82,"data":131},{"doc_id":79,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":4,"category_id":55,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":139,"language":140,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":12,"update_tm":80,"read_time":144,"preview_page_count":4},7971461740886,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","Process Analytical Technologies (PAT)  \nand Quality by Design  \n-the Impact for Process Systems Engineering  \nJulian Morris 1 , Zengping Chen2 and David Lovett3  \n1 Centre for Process Analytics & Control Technology, Newcastle & Strathclyde Univ. UK  \n2State Key Laboratory of Chemo/Biosensing & Chemometrics, Hunan University, China  \n3 Perceptive Engineering, Daresbury Innovation Centre, Daresbury, Cheshire, UK  \n[www.cpact.com](www.cpact.com)  \n“To Honour the Life-long Contribution of Professors Anastasios Karabelas and Stavros Nychas to Chemical Engineering in Greece”  \nSymposium on New Frontiers in Chemical & Biochemical Engineering, Thessaloniki, 26-28 Nov 2009  \nOverview of Presentation  \n􀂄 An overview of some of the pharma-sector challenges  \n􀂄 Process Analytical Technologies:  \nz Where have we come from? Where are we now?, Where are we going?  \n􀂄 Some challenges in spectroscopic data pre-processing and modelling  \nz Applications in Crystallisation and other industrial problems  \n􀂄 Variability - Different Product Formulations, Recipes, Processing Units, Production Sites, Spectroscopic Probe Locations,….  \n􀂄 Closing the Analytical Control Loop  \n􀂄 Closure  \nThe EU provides 32% of the worlds chemicals manufacturing through some 25,000 enterprises of which 98% are SMEs which account for 45% of the sectors ‘added value’, and 46% of all  \nemployees are in SME  \nWhat does PAT, QbD and Real-Time-Release  \nmean to an SME?  \nBenchmarks for Pharmaceuticals Companies  \n\n| PHARMACEUTICAL BENCHMARKS |  |  |  |\n| --- | --- | --- | --- |\n| KPI’s | Present Pharmaceutical Industry | A Winning Pharmaceuticals Plant | A World Class Pharmaceuticals Manufacturing Plant |\n| Stock Turn | 3 to 5 | 14 | 50 |\n| OTIF | 60% to 80% | 97 .4% | 99 .6% |\n| RFT | 85% to 95% | 96% | 99 .4% |\n| CpK | 1 to 2 | 3 .5 | 3 .2 |\n| OEE | 30% | 74% | 92% |\n\nStock Turn-this is the total turnover on the site at manufacturing price divided by all the stocks on the site on the same basis. Stocks include finished goods, work in progress, and purchased raw materials; On Time in Full (OTIF) delivery-this is the percentage of orders that are satisfied on time in full with zero defects; Right First Time (RFT) -this is the percentage of the products that at the point of manufacture are delivered right first time with no defects; CpK-is a statistical process measure on the variability of the product; Overall Equipment Effectiveness (OEE) -this measures how effectively the manufacturing equipment is used.  \nBenson R.S, From World Class Research to World Class Manufacturing: the Challenges, Pharmaceutical Eng. Sept/Oct 2005  \nCourtesy Staffan  \nFolestad AstraZeneca, APACT09  \nCourtesy Staffan  \nFolestad AstraZeneca, APACT09  \nReal Time Release (RTR)  \nCourtesy Staffan  \nFolestad AstraZeneca, APACT09  \nThe Principles of a ‘Process’ Systems Base Approach  \nCourtesy Staffan  \nFolestad AstraZeneca, APACT09  \nWhere are we in  \nProcess Analytics and Control Technologies?  \nHeterogeneity  \n􀂄 Heterogeneity can be influenced by the manufacturing process.  \nz Different product variants arising  \n• from varying raw materials  \n• from upstream processing issues  \n• from downstream processing changes  \n• from utilities issues  \n•  \n………","cbCaig9LmtXWCQMc","https://ap.wps.com/l/cbCaig9LmtXWCQMc","pdf",4556610,57,"English","# Overview of Presentation\n## Pharma-sector challenges and PAT evolution\n## Spectroscopic data pre-processing and modelling\n## Applications in crystallisation and industrial problems\n## Variability and sources across manufacturing\n## Closing the analytical control loop\n# SME interpretation of PAT, QbD, and real-time release\n## Benchmark KPIs and definitions","[{\"question\":\"What major pharma-sector challenges are addressed in the presentation?\",\"answer\":\"It covers challenges faced by the pharmaceutical sector and positions PAT and QbD within process systems engineering. It also highlights issues tied to spectroscopic data modelling and operational variability across manufacturing contexts.\"},{\"question\":\"How does the presentation connect variability to PAT and QbD?\",\"answer\":\"Variability is linked to different product formulations, recipes, processing units, production sites, and spectroscopic probe locations. It also notes that heterogeneity can be influenced by the manufacturing process and upstream/downstream changes.\"},{\"question\":\"What KPI benchmarks are used to compare pharmaceutical manufacturing performance?\",\"answer\":\"Benchmarks include Stock Turn, OTIF (On Time in Full), RFT (Right First Time), CpK (process variability measure), and OEE (Overall Equipment Effectiveness). The document defines each metric and contrasts performance across plant categories.\"}]","Process Analytical Technologies (PAT) and Quality by Design - The Impact for Process Systems Engineering | PDF",144]