Comparison on Good Manufacturing Practices (GMPs) of FDA’s Drug and Dietary Supplement (21 CFR Parts 211 vs. 111)
Both drug and dietary supplement GMPs ensure the quality and safety of products, but they differ significantly in scope, control systems, personnel requirements, facility standards, production controls, laboratory controls, documentation, complaint handling, and reporting. Below are the key differences between FDA's Drug and Dietary Supplement GMPs (21 CFR Parts 211 against 111). 1. Scope and Purpose Drugs (21 CFR Part 211): Ensures the safety, efficacy, and quality of pharmaceutical products. Applies to all manufacturing stages, including processing, packing, or holding. Focuses on therapeutic drugs, biological products, and certain medical devices. Dietary Supplements (21 CFR Part 111): Ensures identity, purity, quality, strength, and composition of dietary supplements. Applies to manufacturing, packaging, labeling, and holding of dietary supplements. Focuses on vitamins, minerals, herbs, amino acids, and other dietary ingredients. 2. Quality Control Systems Drugs: Requires a ded...
