{"product_id":"pharmaceutical-manufacturing-handbook-regulations-and-quality-pharmaceutical-development-series","title":"Pharmaceutical Manufacturing Handbook: Regulations and Quality (Pharmaceutical Development Series)","description":"\u003cp\u003e\u003cstrong\u003eBook info:\u003c\/strong\u003e Pharmaceutical Manufacturing Handbook: Regulations and Quality (Pharmaceutical Development Series) (Hardcover, 856 pages) – Wiley-Interscience, 2008. Language: English.\u003c\/p\u003e\n With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.  \n        From the Back Cover   Everything you need to ensure full compliance and superior quality control\u003cp\u003eWith its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines.\u003c\/p\u003e\u003cp\u003eThe team of expert authors, all familiar with the many issues involved in compliance and quality control, offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing. The editor, who has more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.\u003c\/p\u003e\u003cp\u003eAmong the key topics covered are:\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\u003cp\u003eEnforcement of current good manufacturing practices\u003c\/p\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cp\u003eInspections by health regulatory agencies\u003c\/p\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cp\u003eCreating and managing a quality management system\u003c\/p\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cp\u003ePersonnel training within pharmaceutical manufacturing\u003c\/p\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cp\u003eMicrobiology of non-sterile pharmaceutical manufacturing\u003c\/p\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cp\u003ePharmaceutical manufacturing validation principles\u003c\/p\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eFollowing the handbook's carefully developed guidelines and advice helps you ensure your company's full compliance and avoid potential costly pitfalls. This publication should be readily accessible to all scientists, engineers, and managers involved in pharmaceutical manufacturing.\u003c\/p\u003e           About the Author   SHAYNE COX GAD, PhD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of twenty-nine books and numerous papers, presentations, and other publications.      ","brand":"Shayne Cox Gad","offers":[{"title":"Default Title","offer_id":46069943042282,"sku":"9780470259597","price":258.01,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0714\/5301\/6298\/files\/81EAcoBextL._SL1500_452f6b19-8f85-4066-ba47-49214005e6e9.jpg?v=1781232847","url":"https:\/\/textbookme.store\/products\/pharmaceutical-manufacturing-handbook-regulations-and-quality-pharmaceutical-development-series","provider":"TextbookMe","version":"1.0","type":"link"}