1st Edition
Dietary Supplement Good Manufacturing Practices Preparing for Compliance
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
Biography
William J. Mead
"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
