What is 21 CFR Part 210?
FDA 21 CFR Part 210—also known as the Current Good Manufacturing Practice (cGMP) in Manufacturing, Processing, Packing, or Holding of Drugs—is a critical regulation that sets the standard for quality in the pharmaceutical industry. This guideline ensures that drugs are consistently produced, controlled, and distributed in a manner that meets the Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements.
21 CFR Part 210 outlines the cGMP drug regulations in three sections:
- 210.1 Status of current good manufacturing practice regulations. This section explains the purpose and scope of cGMP and the consequences of noncompliance.
- 210.2 Applicability of current good manufacturing practice regulations. This section defines which drugs are subject to cGMP and which are exempt.
- 210.3 Definitions. This section defines key terms used in cGMP, such as batch, component, drug product, quality control unit, etc.
These sections provide the basic framework for cGMP and set the expectations for drug manufacturers to ensure the quality and safety of their products.