{"product_id":"volume-1-muralidhar-rao-akkaladevi-9798895199244","title":"Volume 1: Comprehensive Guide to Pharmaceutical Regulatory Affairs: Principles and Practices","description":"\u003cp\u003eComprehensive Guide to Pharmaceutical Regulatory Affairs is an essential resource for anyone involved in the pharmaceutical industry, particularly those working in regulatory affairs. This book provides a thorough understanding of the principles and practices that ensure the safety, efficacy, and quality of pharmaceutical products.\u003c\/p\u003e\u003cp\u003e It begins with\u003cstrong\u003e Good Regulatory Practices, \u003c\/strong\u003e providing a strong foundation in the basic principles of regulatory affairs. Subsequent chapters delve into \u003cstrong\u003eGood Laboratory Practices, Good Automated Laboratory Practices, and Good Distribution Practices\u003c\/strong\u003e, each offering detailed insights into maintaining high standards across different stages of pharmaceutical production and distribution.\u003c\/p\u003e\u003cp\u003eThe section on \u003cstrong\u003eQuality Management Systems\u003c\/strong\u003e explores the implementation of effective quality assurance mechanisms, ensuring that all pharmaceutical products meet stringent quality standards. Detailed chapters on\u003cstrong\u003e Documentation and Regulatory Writing, \u003c\/strong\u003e \u003cstrong\u003eDossier Preparation and Submission\u003c\/strong\u003e, and Audits offer practical guidance on the critical documentation processes and audit procedures required for regulatory approval and ongoing compliance.\u003c\/p\u003e\u003cp\u003eThe book also addresses the complexities of \u003cstrong\u003eInspections and Product Life Cycle Management\u003c\/strong\u003e, providing comprehensive guidance on maintaining compliance throughout the product lifecycle. A comprehensive \u003cstrong\u003eList of Abbreviations and Acronyms and a detailed Bibliography serve as valuable reference tools, \u003c\/strong\u003e enhancing the utility of this guide.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Muralidhar Rao Akkaladevi,Veerareddy Prabhakar Reddy\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798895199244\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Notion Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 08\/13\/2024\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 352\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.40lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.96d","brand":"Muralidhar Rao Akkaladevi","offers":[{"title":"Paperback","offer_id":48446894604543,"sku":"9798895199244","price":27.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_c8a0fdc4-b6e4-407a-9c2b-417b8326fe3b.jpg?v=1777227440","url":"https:\/\/www.whiterainbookhouse.com\/products\/volume-1-muralidhar-rao-akkaladevi-9798895199244","provider":"WR Book House","version":"1.0","type":"link"}