Dietary Supplements

Good Dietary Supplement Practice Training Objectives

• The 11 General Orders of GMP
  - Writing Procedures
  - Following Procedures
  - Good Documentation Practice
  - Validation
  - Design/Build Facilities
  - Maintain Facilities
  - Training, Education and Experience
  - Sanitation and Housekeeping
  - Control for Quality
  - Audit for Compliance
  - Prepare for Battle - Recall/Traceability

• US FDA 21 CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

 

US FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures

• 21 CFR Part 11 History and Overview

• 21 CFR Part 11 a) - k) Requirements