Overview

Dietary Supplement GMP is a one-stop ""how-to"" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products. The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances—leaving implementation to the discretion of each firm. Given this latitude and flexibility, this new resource is an essential source of workable and practical suggestions on ways the industry can best meet the goals. Based on broad experience with GMP compliance techniques worked out over the years in the food, drug, and medical device industries, it is a must-have guide for all DS companies, especially the many smaller firms for whom this is new territory. Dietary Supplement GMP provides: a practical guide in easy to understand language to help navigate through the requirements for systems covering process and quality control suggestions and practical recommendations on ""how-to"" achieve full compliance explanation of the FDA’s role regarding inspection, enforcement, recall/seizure of products and prosecution Dietary Supplement Good Manufacturing Practices (GMP) covers: Personnel Plants and Grounds Equipment and Utensils Sanitation of Buildings and Equipment Quality Assurance and Laboratory Operations The Quality Control Unit Production and Process Controls

Full Product Details

Author:   William J. Mead (Rowayton, Connecticut, USA)
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Dimensions:   Width: 15.20cm , Height: 1.20cm , Length: 22.90cm
Weight:   0.544kg
ISBN:  

9781420077407

ISBN 10:   1420077406
Pages:   312
Publication Date:   17 November 2011
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

The Basics of Good Manufacturing Practice. Regulatory Overview. Personnel Matters. Physical Plant and Grounds. Equipment and Utensils. Cleaning and Sanitation. Maintenance and GMP. Calibration. Production and Process Controls. Specifications. Sampling. Deviations and Corrective Actions. Incoming Components, Packaging Materials and Labels. Master Manufacturing Record. Batch Production Record. Manufacturing Operations. Packaging and Labeling Operations. Quality Control Responsibilities. Laboratory Operations. Returned Goods. Product Complaint Handling. Holding and Distributing. Handling Recalls. Top Management Responsibility. Record Keeping, Documentation, SOPs. Change Control. Adverse Event Reporting and Records Keeping. Continuous Improvement. Supply Chain Integrity. Audits. Outsourcing. The FDA. FDA Inspections.

Reviews

This book may therefore become a useful tool to further the implementation of more modern approaches towards product safety and quality and to actually help transitioning dietary supplements to become food also in real life and not only from a regulatory stand point. -Elena Vittadini, International Journal of Food Science and Nutrition Bill Mead's primer Dietary Supplement Good Manufacturing Practices - Preparing for Compliance, should be required reading for every quality control department in the supplement industry. The book dissects and digests the FDA's lengthy regulations and preamble, making the minutiae of a very complicated rulemaking understandable so the requirements can actually be implemented. Bill Mead offers not only what the rule requires but how to comply, and why each topic is critical to pass your next inspection. Conscientious firms will want to read cover to cover before the FDA inspector knocks on the door. -Steve Mister, President & CEO, Council for Responsible Nutrition

<p> This book may therefore become a useful tool to further the implementation of more modern approaches towards product safety and quality and to actually help transitioning dietary supplements to become food also in real life and not only from a regulatory stand point. - Elena Vittadini, International Journal of Food Science and Nutrition

Author Information

William J. Mead

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