Biotility: CGMP for Dietary Supplements

Dietary supplements are regulated by the FDA per 21 CFR §111.  This module defines and describes dietary supplements and their ingredients, and outlines the CGMP controls that companies must establish and maintain to ensure the products they manufacture or distribute are safe, consistently produced, and meet the quality standards established for their intended use.

Recommended Use: Required
ID (Language): 20698 (English)
Author(s): Harry W. Rambo, Jr, AS - Thermo Fisher Scientific

Dietary supplements marketed in the United States are regulated under Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (21 CFR §111), the Dietary Supplement Health and Education Act (DSHEA), and the Federal Food, Drug, and Cosmetic Act. Regulatory requirements include establishing and maintaining a system of controls to ensure consistency for all operations involved in the manufacture, testing, labeling, packaging, and/or holding of dietary supplements. This module describes company responsibilities and operational controls for departmental personnel, training, documentation, labeling, materials and components, processing, equipment, instruments, utensils, contamination controls, as well as requirements for facilities and maintenance of a physical plant.

Recommended Use: Required
ID (Language): 20699 (English)
Author(s): Harry W. Rambo, Jr, AS - Thermo Fisher Scientific

This module explains manufacturing and quality assurance/quality control operations, the requirements for packaging, labeling, holding, and distribution of dietary supplements, and management of product returns and complaints for dietary supplements, as well as components and ingredients of dietary supplements. Requirements for master manufacturing records and batch production records are described. The module also explores establishment of process and facility controls, applications of Good Documentation Practices, and requirements for distributors of dietary supplements. Learners will also review the methods for material reviews for returned dietary supplements and for investigating product complaints are described.

Recommended Use: Required
ID (Language): 20700 (English)
Author(s): Harry W. Rambo, Jr, AS - Thermo Fisher Scientific

This module reviews the consequences of noncompliance with 21 CFR §111, including FDA Form 483 and FDA Warning Letters. A hypothetical case study enables learners to consider methods for meeting the regulatory requirements of 21 CFR §111. The case study reinforces the value and importance of regulatory compliance and highlights how compliance helps to ensure dietary supplements are safe for the end user or consumer.

Recommended Use: Required
ID (Language): 20711 (English)
Author(s): Harry W. Rambo, Jr, AS - Thermo Fisher Scientific