Dietary Supplement Good Manufacturing Practices: Preparing for Compliance, 1st Edition (Hardback) book cover

Dietary Supplement Good Manufacturing Practices

Preparing for Compliance, 1st Edition

By William J. Mead

CRC Press

298 pages

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Hardback: 9781420077407
pub: 2011-11-17
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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

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

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

Subject Categories

BISAC Subject Codes/Headings:
MED060000
MEDICAL / Nutrition
MED071000
MEDICAL / Pharmacology