Compact Regs Parts 110 and 111: CFR 21 Parts 110 and 111 cGMP in Manufacturing

Compact Regs Parts 110 and 111: CFR 21 Parts 110 and 111 cGMP in Manufacturing

Author: Interpharm

Publisher: CRC Press

Published: 2003-11-17

Total Pages: 36

ISBN-13: 1420025813

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Supplemented with a handy keyword index, the Compact Regs series provides pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The text is complete and has not been altered in any manner from the original source. Compact Regs Parts 110 and 111 covers good manufacturing practices for acid foods and batters. It describes prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and effect other physical or biochemical changes in the food. It covers critical control points in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food, or decomposition of the final food. In short, the book covers food safety in food processing and manufacturing from the field to packaging and storage. This is the perfect low-cost tool for: employees as part of documented GMP training programs; suppliers/vendors so that they may provide components, labels, and parts with an understanding compliant with FDA requirements; and technicians charged with ensuring adherence to US FDA regulations.


Compact Regs CFR 21

Compact Regs CFR 21

Author: Food and Drug Administration

Publisher: CRC Press

Published: 2004-06-02

Total Pages: 56

ISBN-13: 9781135489595

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The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources. They are the perfect low-cost tools for: employees as part of documented GMP training programs, for suppliers/vendors so that they may provide components, labels, and parts with an understanding of FDA requirements, and for each clinical investigator, nurse, and technician to help assure compliance to clinical trial protocols. There is a keyword index that can be found at the end of each booklet.


Dietary Supplement Regulation in the United States

Dietary Supplement Regulation in the United States

Author: Taylor C. Wallace

Publisher: Springer Science & Business Media

Published: 2013-10-01

Total Pages: 51

ISBN-13: 3319015028

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Contrary to the common belief that dietary supplements are “unregulated” in the United States, nutrients and other dietary ingredient-containing products have been regulated in this country for a little over a century at least in some capacity, initially through the Pure Food and Drug Act (PFDA) of 1906 and culminating with the many anticipated regulations to be implemented following the recent enactment of the Food Safety Modernization Act of 2010 (FSMA). The goal of this brief is to review and discuss the current statutes and regulations surrounding the ingredients, manufacturing standards, safety, and labeling of dietary supplements for the purpose of protecting consumers. ​


Food Law and Regulation for Non-Lawyers

Food Law and Regulation for Non-Lawyers

Author: Marc C. Sanchez

Publisher: Springer

Published: 2014-12-09

Total Pages: 248

ISBN-13: 3319124722

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The book offers a succinct overview of key topics and core concepts for food scientists, quality managers, and others who need to understand the regulation of food and dietary supplements in the U.S. It was designed and modeled after a six-week introduction to food law course currently taught at Northeastern University, and serves as a practical tool for regulatory professionals. The book includes a chapter on each major topic, with summations of the legislative history and general legal landscape. Each chapter focuses the reader on major and emerging issues encountered by facilities. A comparative law section at the end of every chapter offers readers an ability to view alternative methods of regulation and enforcement. This design is unique and allows students and working professionals alike to understand core concepts and the practical application of the law to their work. Using a modified casebook method approach, the book also serves as a practical tool for regulatory professionals.


Advances in Fresh-Cut Fruits and Vegetables Processing

Advances in Fresh-Cut Fruits and Vegetables Processing

Author: Olga Martin-Belloso

Publisher: CRC Press

Published: 2010-10-21

Total Pages: 424

ISBN-13: 1420071238

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Despite a worldwide increase in demand for fresh-cut fruit and vegetables, in many countries these products are prepared in uncontrolled conditions and have the potential to pose substantial risk for consumers. Correspondingly, researchers have ramped up efforts to provide adequate technologies and practices to assure product safety while keeping n


Food Regulation

Food Regulation

Author: Neal D. Fortin

Publisher: John Wiley & Sons

Published: 2016-10-25

Total Pages: 1028

ISBN-13: 1118964497

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Featuring case studies and discussion questions, this textbook – with revisions addressing significant changes to US food law – offers accessible coverage appropriate to a wide audience of students and professionals. Overviews the federal statutes, regulations, and regulatory agencies concerned with food regulation and introduces students to the case law and statutory scheme of food regulation Focuses updated content on the 2011 FDA Food Safety Modernization Act (FSMA), the biggest change to US food law since the 1930s Contains over 20% new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense Features case studies and discussion questions about application of law, policy questions, and emerging issues


Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2008-03-11

Total Pages: 1386

ISBN-13: 0470259809

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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with 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.


Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook

Author: Shayne Cox Gad

Publisher: John Wiley & Sons

Published: 2008-04-04

Total Pages: 857

ISBN-13: 0470259825

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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.