William J. Mead
Published November 17, 2011
Reference - 298 Pages
ISBN 9781420077407 - CAT# H7740
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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:
Dietary Supplement Good Manufacturing Practices (GMP) covers:
The Basics of Good Manufacturing Practice
Physical Plant and Grounds
Equipment and Utensils
Cleaning and Sanitation
Maintenance and GMP
Production and Process Controls
Deviations and Corrective Actions
Incoming Components, Packaging Materials and Labels
Master Manufacturing Record
Batch Production Record
Packaging and Labeling Operations
Quality Control Responsibilities
Product Complaint Handling
Holding and Distributing
Top Management Responsibility
Record Keeping, Documentation, SOPs
Adverse Event Reporting and Records Keeping
Supply Chain Integrity
"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