[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-243819-105":53,"doc-detail-243819-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","developing-effective-procedures-whitepaper","Developing Effective Procedures - Whitepaper","","Developing Effective Procedures presents a structured, risk-based approach to designing controlled documentation systems for pharmaceutical manufacturing. It emphasizes that effective control is achieved through an integrated process—knowledge management, change management, and risk management—rather than treating procedures as the entire control system. The roadmap guides organizations to evaluate product lifecycle position, product type, and available resources, then build a state of control that supports patient safety, efficient product realization, and continual improvement.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/developing-effective-procedures-whitepaper/243819/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/developing-effective-procedures-whitepaper/243819.png","ImageObject",442,249,{"name":88,"@type":89},"Connor ","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-19","2026-09-12",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",10,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"Why should an organization focus on understanding why a procedure is written?","Question",{"text":109,"@type":110},"The document argues the first step is understanding the purpose behind the procedure so it fits into an overall controlled process that supports patient safety and product quality.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"How does the document redefine the role of procedures in a documentation system?",{"text":114,"@type":110},"It states an effective documentation system is a process for maintaining control, where procedures are functional tools within that process, not the complete control system.",{"name":116,"@type":107,"acceptedAnswer":117},"What are the three foundation processes recommended for building effective procedural controls?",{"text":118,"@type":110},"The recommended foundation is Change Management, Risk Management, and Knowledge Management, integrated before editing or creating procedures.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},243819,1791716006,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":141,"read_time":76},687207022233,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","ARE YOU READY?  \nWHITEPAPER  \nDEVELOPING EFFECTIVE  \nPROCEDURES  \nBY JEFF HALL & LISA HAWKINS  \nDeveloping Effective Procedures  \nNeeding to develop or update your procedures? Are you sitting at your computer starting to write procedures for every subject discussed in regulations and standards, addressing each statement with a procedural step? Put the procedure template away. The first step to writing effective procedures is in understanding WHY you are writing that procedure.  \nAs everyone knows, a QMS/GMP/SOP controlled document system is made up of a certain set of procedures that get the job done, right? Let’s challenge that idea. An effective documentation system is not a series of procedures: it is a process by which the organization will maintain a state of control that ensures patient safety by manufacturing products that are safe and efficacious. This doesn’t happen because of procedures. Procedures are functional tools of a controlled process but are not the entirety of a control system.  \nBefore fingers are ever put to a keyboard to start writing a procedure, the organization should evaluate its place in the product lifecycle, the type of product it is manufacturing, and the resources it has available to implement effective procedural controls. An organization with fewer than 50 people will end up with a different system than a multi-site organization with 50 people in one group. The path to get there, however, can be the same regardless of the organization.  \nWe recommend a structured approach to understanding what your controls should be based on a foundation of three key processes: Change Management, Risk Management, and Knowledge Management. This is not to say that the remainder of the elements from ICH Q10 are not critical. They will be integrated as the structure is built. The elements and enablers and their role in product lifecycle are shown below.  \nICH Q10 Pharmaceutical Quality System  \nPharmaceutical Development  \nTechnology Transfer  \nCommercial Manufacturing  \nProduct  \nDiscontinuation  \nInvestigational Products  \nGMP  \nManagement Responsibilities  \nPQS Elements  \nProcess Performance & Productive Quality Monitoring System Corrective Action / Preventative Action (CAPA) System Change Management Systems  \nManagement Review  \nEnablers  \nKnowledge Management  \nQuality Risk Management  \n2  \nDEVELOPING EFFECTIVE PROCEDURES  \nThe proposed roadmap requires stepping back to the basic structure of these three systems (Knowledge Management, Change Management, Risk Management) and how they integrate with each other before editing or creating procedures. The primary goal is to create a thoughtful structure of processes and procedures that interact appropriately where procedure adherence does not become an administrative task. The resulting system ensures efficient product realization, establishes a state of control, and facilitates continual improvement. Across-functional team can be used to determine process owners and the purpose of the process (why do we need a CAPA process? Hint: “because FDA says so” is not the correct answer here) .  \nQUALITY RISK MANAGEMENT  \nKnowledge Management  \nChange Management  \nRisk Management  \nRegulatory authorities have been evaluating drugs, devices, and other products and the companies that make them using a risk-based approach for many years and have had an expectation that the companies themselves are approaching their system control using a Quality Risk Management methodology (ICH Q9) . Companies that function only in a basic compliant state (i.e., all procedures and processes are based only on 21 CFR 210/211 Current Good Manufacturing Practice for Finished Pharmaceuticals) will be missing this key element as risk itself is never mentioned directly in the regulations. Therefore, using all available knowledge regarding risk management is key to building a good foundation. ICH Q9 Quality Risk Management (QRM) should be used to incorporate risk management into all aspects of the Q","cbCaicPc3lZcy1ZK","https://ap.wps.com/l/cbCaicPc3lZcy1ZK","pdf",1444200,7,"English","# Developing Effective Procedures\n## Core principle: procedures as tools within a controlled process\n## Roadmap using three key systems\n## Quality Risk Management (ICH Q9)\n## Change Management System","[{\"question\":\"Why should an organization focus on understanding why a procedure is written?\",\"answer\":\"The document argues the first step is understanding the purpose behind the procedure so it fits into an overall controlled process that supports patient safety and product quality.\"},{\"question\":\"How does the document redefine the role of procedures in a documentation system?\",\"answer\":\"It states an effective documentation system is a process for maintaining control, where procedures are functional tools within that process, not the complete control system.\"},{\"question\":\"What are the three foundation processes recommended for building effective procedural controls?\",\"answer\":\"The recommended foundation is Change Management, Risk Management, and Knowledge Management, integrated before editing or creating procedures.\"}]","Developing Effective Procedures - Whitepaper | PDF",1789209067]