Dietary Supplement Good Manufacturing Practices : Preparing for Compliance book cover
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Dietary Supplement Good Manufacturing Practices
Preparing for Compliance




ISBN 9781420077407
Published November 17, 2011 by CRC Press
298 Pages

 
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Book Description

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

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

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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