1st Edition

Dietary Supplement Good Manufacturing Practices Preparing for Compliance

By William J. Mead Copyright 2012

    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

    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