21 CFR Part 820 - Quality System Regulation-- Quality System Requirements, Design, Document, Purchasing control, Production and Process Controls, Labeling and Packaging Control

• Date: February 11, 2010
• Source: www.fda.gov

Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act).
 

This regulation is divided in to 15 subparts ranging from A to O. This page contains  the underlying requirements of  Subpart B, C, D, E and K of the regulation which deals with Quality System Requirements, Design, Document, Purchasing Control, Production and Process Controls, Labeling and Packaging Control.