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It summarizes present ICH quality initiatives and ISPE involvement, and reviews distant assessments, audits, and GMP regulatory guidance in the context of the COVID-19 pandemic. Technical features address cleanroom design and energy-related considerations under ISO 14644-16, plus temperature and humidity requirements for pharmaceutical facilities, alongside departments and events.",{"@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":30,"@type":76,"position":81},"https://docshare.wps.com/document/technology/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/pharmaceutical-engineering-september-october-2021-complete-issue/673105/",{"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/pharmaceutical-engineering-september-october-2021-complete-issue/673105.png","ImageObject",300,407,{"name":92,"@type":93},"sagouaw","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-02",true,{"@type":101,"interactionType":102,"userInteractionCount":8},"InteractionCounter",{"@type":103},"ViewAction",{"@type":105,"mainEntity":106},"FAQPage",[107,113,117],{"name":108,"@type":109,"acceptedAnswer":110},"What topics are emphasized in the September-October 2021 focus section?","Question",{"text":111,"@type":112},"The issue emphasizes regulatory trends and quality initiatives, including ICH Q12, ICH quality guidelines and ISPE involvement, and distant assessments, audits, and regulatory guidance.","Answer",{"name":114,"@type":109,"acceptedAnswer":115},"How does the issue connect innovation and regulation?",{"text":116,"@type":112},"It presents PQLI® as a long-term ISPE initiative working at the nexus of pharmaceutical manufacturing technology and regulation to advance new regulatory and technology approaches.",{"name":118,"@type":109,"acceptedAnswer":119},"What technical areas does the issue cover for pharmaceutical facilities?",{"text":120,"@type":112},"It includes pharmaceutical cleanroom design and energy-related calculations aligned with ISO 14644-16, and it addresses defining temperature and humidity requirements for pharmaceutical facilities.","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},673105,1793620416,{"code":4,"msg":5,"data":130},{"doc_id":127,"user_id":131,"nickname":92,"user_avatar":132,"doc_module":4,"category_id":29,"category_name":30,"doc_title":65,"doc_description":67,"doc_content":133,"file_id":134,"file_url":135,"file_type":136,"file_size":137,"view_count":8,"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},3985747862151,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","The O cial Magazine of ISPE  \nSeptember-October 2021 | Volume 41, Number 5  \nFOCUS on Regulatory Trends/Quality Initiatives  \nA Vision for ICH Q12: Current Experience, Future Perspectives  \nICH Quality Guidelines: Present Initiatives and ISPE Involvement PQLI®: Advancing Innovation and Regulation  \n[ISPE.org/pharmaceutical-engineering](ISPE.org/pharmaceutical-engineering)  \nNEW SKAN VarioSys Isolator Flexible Modular Production Isolator perfect for Cell & Gene processing  \nOne system, many missions!  \nUltra-fast SKANFOG® decontamination cycle Integrated NANOX ® catalyst technology  \nSmall-scale clinical or cGMP commercial production  \nVisit us at:  \n2021  \nSKAN Booth  \nOCTOBER 19-21 JAVITS CENTER | NYC  \n\\#3140  \nBausch+Ströbel Booth \\#2505B  \nSKAN US is based in Raleigh, NC. We offer exceptional local customer service and support  \nSKAN Academy: seminars and training US-based service organization  \n24/7 Emergency Service Support Large US-based automation support Spare parts inventory in Raleigh, NC SKAN BIs, H2O2, and micro lab support  \nFor more information call SKAN US today at:  \n+1 919 354 6380 or email: [sales@us.skan.ch](sales@us.skan.ch)  \nSKAN US, Inc.  \n7409 ACC Blvd., Suite 200 Raleigh, NC 27617  \nUSA  \nSKANAG Kreuzstrasse 5 4123 Allschwil Switzerland  \nVarioSys – Four partner – one system  \nMore [information at: variosys.com/en](information at: variosys.com/en)  \nBausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG Parkstraße 1  \n74532 Ilshofen Germany  \nPhone +49 7904 701-0  \nDelivering Solutions to Better Serve Your Patients Engineering, Procurement, Construction and CQV Services  \nLeverage our Subject Matter Experts to accelerate your product delivery platform with quality solutions: Biotechnology | Pharmaceutical | Vaccines  \nFor decades, Fluor has designed and built various types of bulk pharmaceutical facilities, employing batch, semi-continuous and continuous operations. We offer the pharmaceutical industry agility and robustness through expertise in process design and providing innovative professional and technical solutions.  \n[www.fluor.com](www.fluor.com)  \n© 2021 Fluor Corporation. All rights reserved. Fluor is a registered service mark of Fluor Corporation.  \nADGV205921 A  \nIMPROVE OPTIMIZE GROW  \nFUEL YOUR SUCCESS.  \nENGINEERING | ARCHITECTURE | CONSTRUCTION | CONSULTING  \n[crbgroup.com](crbgroup.com)  \nSEPTEMBER / OCTOBER 2021  \n14 A VISION FOR ICH Q12: CURRENT EXPERIENCE, FUTURE PERSPECTIVES  \nManagement of global postapproval chemistry, manufacturing, and controls changes is a growing challenge for industry with many issues. ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) is a transformative document shaping global regulatory postapproval submissions that will help alleviate some of these issues.  \n24 ICH QUALITY GUIDELINES: PRESENT INITIATIVES AND ISPE INVOLVEMENT  \nThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has covered awide range of topics to generate quality, safety, e cacy, and multidisciplinary harmonized guidelines. This article summarizes all quality and related multidisciplinary guidelines and discusses new topics and ISPE’s role in guideline development and implementation.  \n34 DISTANT ASSESSMENTS, AUDITS, AND REGULATORY GUIDANCE  \nThe ISPE Global Pharmaceutical Regulatory Summit, held virtually on 28 April 2021, brought together 11 regulators from di􀀞erent parts of the world to discuss how their approaches to GMP inspectionshave adapted to theCOVID-19 pandemic.  \nON THE COVER The in-focus capsule standing out from many capsules represents the clarity of regulatory and quality initiatives highlighted in this issue.  \n2 P ha r ma c e ut i ca l Eng i n eer i ng  \nSEPTEMBER / OCTOBER 2021  \n40 PQLI® : Advancing Innovation and Regulation  \nA unique aspect of the pharmaceutical industry is the pairing of innovation and regulation. For nearly two decades, ISPE’s Product Quality Li","cbCaiu58Y0nxwOuV","https://ap.wps.com/l/cbCaiu58Y0nxwOuV","pdf",7788974,81,"English","# FOCUS on Regulatory Trends/Quality Initiatives\n## A Vision for ICH Q12: Current Experience, Future Perspectives\n## ICH Quality Guidelines: Present Initiatives and ISPE Involvement\n## PQLI®: Advancing Innovation and Regulation\n## Distant Assessments, Audits, and Regulatory Guidance\n# Departments\n## Message from the Chair\n## Emerging Leaders\n## Women in Pharma® Editorial\n## People + Events\n# Technical\n## Pharmaceutical Cleanroom Design and ISO 14644-16\n## Temperature and Humidity Requirements in Pharmaceutical Facilities","[{\"question\":\"What topics are emphasized in the September-October 2021 focus section?\",\"answer\":\"The issue emphasizes regulatory trends and quality initiatives, including ICH Q12, ICH quality guidelines and ISPE involvement, and distant assessments, audits, and regulatory guidance.\"},{\"question\":\"How does the issue connect innovation and regulation?\",\"answer\":\"It presents PQLI® as a long-term ISPE initiative working at the nexus of pharmaceutical manufacturing technology and regulation to advance new regulatory and technology approaches.\"},{\"question\":\"What technical areas does the issue cover for pharmaceutical facilities?\",\"answer\":\"It includes pharmaceutical cleanroom design and energy-related calculations aligned with ISO 14644-16, and it addresses defining temperature and humidity requirements for pharmaceutical facilities.\"}]","Pharmaceutical Engineering - September / October 2021 - Complete Issue | PDF",204]