[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-354905-105":53,"doc-detail-354905-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","cleaning-validation-master-plan-template","Cleaning Validation Master Plan Template","","Cleaning Validation Master Plan Template provides a comprehensive framework to ensure proper cleaning and sanitization of manufacturing equipment used for tablets and hard gelatin capsules. It defines responsibilities across protocol preparation, execution, review, and approval; includes coordination for sample collection; and establishes training for involved personnel. The plan specifies worst-case product selection using API water solubility, potency, and cleaning difficulty, supports product matrices, MACO-based evaluation, and rules for impact analysis and re-validation when products, agents, or equipment change.",{"@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":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/cleaning-validation-master-plan-template/354905/",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/cleaning-validation-master-plan-template/354905.png","ImageObject",442,249,{"name":88,"@type":89},"Adam","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-23","2026-09-22",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",7,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What equipment and dosage forms are covered by the cleaning validation master plan?","Question",{"text":109,"@type":110},"It covers equipment used in manufacturing tablets and hard gelatin capsules and defines how cleaning and sanitization are validated for these solid oral dosage forms.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"How are worst-case products selected for cleaning validation?",{"text":114,"@type":110},"Products are selected based on API water solubility, drug potency, and difficulty of cleaning. If multiple products meet criteria, they can be validated together; if a single API exists, the lowest water-solubility product is chosen.",{"name":116,"@type":107,"acceptedAnswer":117},"When is re-validation or cleaning verification required?",{"text":118,"@type":110},"Re-validation is required when cleaning agents or procedures change. Cleaning verification is also applied when introducing or replacing equipment, including new equipment additions to a train, using impact analysis forms and appropriate worst-case swab positions.","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},354905,1791573248,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":35,"category_name":36,"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":73,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":9},1374404737137,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Cleaning validation master plan template  \nValidation master plan template free. Cleaning validation report template. Cleaning validation master plan. Master validation plan template.  \nThe Cleaning Validation Master Plan serves as a comprehensive guide for ensuring the proper cleaning and sanitization of equipment used in the manufacture of tablets and hard gelatin capsules. This plan is designed to meet current national and international regulatory standards, particularly those related to manual cleaning procedures. The scope of this plan includes solid oral dosage forms such as tablets and capsules. Responsibilities for the cleaning validation process include preparation, execution, review, and approval of the protocol, coordination with manufacturing for sample collection, ensuring equipment cleanliness, and providing training to personnel involved in cleaning validation. When evaluating the quality and purity of a pharmaceutical product, certain criteria must be met to ensure compliance with established specifications. The process involves identifying the \"worst case\" scenario from each equipment train based on factors such as solubility in water and potency. This worst case may not necessarily be the same for each equipment train. For cleaning validation purposes, products are selected based on their active pharmaceutical ingredient (API) solubility in water, most potent drug product, and difficulty in cleaning. If two or more products meet these criteria, they can be selected together for validation. In cases where a single API is present, the product with the lowest solubility in water is chosen for cleaning validation. A product matrix is developed to track the worst-case products from each equipment train, and cleaning validation is conducted for three batches. New products entering the matrix undergo an impact analysis based on their solubility and potency criteria. Changes in cleaning agents or procedures require re-validation. Additionally, if equipment is not dedicated to a specific product, it must be considered in the relevant equipment train matrix for MACO calculation purposes. Equipment trains are subcategorized into groups based on identical or interchangeable pieces, operating principle, and surface area. The largest capacity equipment with the same cleaning procedure is prioritized for calculations. Any changes to equipment that do not fit within established training categories require re-validation. The process of introducing new equipment to a train will involve performing cleaning verification procedures. For certain instruments, refer to worst-case swab positions and swab identification points. If a new piece of equipment is added to the train, an impact analysis shall be conducted using the new equipment evaluation form. Cleaning verification will also be applied when introducing or replacing equipment on the train, following evaluation and validation as needed. In cases where cleaning verification is required, it will establish the proper removal of target product residue and approved detergent, ensuring that subsequent drug products manufactured on the same equipment are not affected by changes to safety, identity, strength, purity, or quality. The criteria for swab position selection include difficult-to-clean locations and worst-case sampling history. The analytical method used must be qualified for sensitivity and swab recovery. Cleaning techniques employed in the tablet and capsule area involve routine manual cleaning with potable water, followed by manual removal of adhered powder using a nylon brush and 2% self-foaming neutral cleaner. Surfaces are then rinsed with purified water and dried using filtered compressed air or a clean lint-free cloth. For ancillary equipment used in conjunction with main equipment on the train, cleaning validation will be established to ensure effective cleaning procedures. To evaluate the cleaning procedure's effectiveness, methods such as visual inspection, swab","cbCailmqZog5rL0P","https://ap.wps.com/l/cbCailmqZog5rL0P","pdf",44177,"English","# Cleaning Validation Master Plan Purpose\n## Scope and Responsibilities\n## Worst-Case Selection and Product Matrix\n## MACO Evaluation and Equipment Train Grouping\n## Cleaning Verification and Re-Validation\n## Sampling, Analytical Methods, and Acceptance Criteria\n## Visual Checks, Investigations, and Corrective Actions","[{\"question\":\"What equipment and dosage forms are covered by the cleaning validation master plan?\",\"answer\":\"It covers equipment used in manufacturing tablets and hard gelatin capsules and defines how cleaning and sanitization are validated for these solid oral dosage forms.\"},{\"question\":\"How are worst-case products selected for cleaning validation?\",\"answer\":\"Products are selected based on API water solubility, drug potency, and difficulty of cleaning. If multiple products meet criteria, they can be validated together; if a single API exists, the lowest water-solubility product is chosen.\"},{\"question\":\"When is re-validation or cleaning verification required?\",\"answer\":\"Re-validation is required when cleaning agents or procedures change. Cleaning verification is also applied when introducing or replacing equipment, including new equipment additions to a train, using impact analysis forms and appropriate worst-case swab positions.\"}]","Cleaning Validation Master Plan Template | PDF",1790114752]