Introduction

The World Health Organization (WHO) defines good manufacturing practices (GMP) as: "All elements in the established practice that will collectively lead to final products or services that consistently meet appropriate specifications and compliance with defined regulations."¹

The main goal of GMP is to prevent adulterated products from entering the marketplace, whether they be blood, progenitor cells, tissue, or pharmaceuticals. Each country or region may have regulations that apply to manufacturing blood and blood components. Meeting one set of GMP regulations does not imply that all regulations are met for the import, export, or regional shipping of a component.

In the United States, the Department of Health and Human Services Food and Drug Administration (FDA) provides guidance for current good manufacturing practices (cGMP) through the Code of Federal Regulations (CFR). The CFR defines the regulations that apply to blood and blood components as well as pharmaceuticals and medical devices. These are the minimum level of standards that a lab can meet and exceed.

In this course, we will first point out the sections in Title 21 of the CFR that include regulations that apply to all drugs, including blood and blood products, and then focus on the regulations that have been specifically applied to the manufacturing of blood and blood components. Not covered in this course are the Clinical Laboratory Improvement Amendments (42 CFR 493) or the manufacturing of tissue (21 CFR 1270 and 1271).