21 Code of Federal Regulations Parts 210 and 211: Current Good Manufacturing Practice Regulations

The Current Good Manufacturing Practice (CGMP) Regulations, 21 Code of Federal Regulations Part 210 and 211, are Federal regulations which describe the minimum current good manufacturing practices for the preparation of drugs and drug products for administration to humans and animals.  They include methods to be used in and the facilities or controls to be used for the manufacturing, processing, packing, or holding of a drug to assure that such drug meets the requirements of the Food Drug and Cosmetic act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.  21 CFR sections 210 and 211 still are the foundation of current industry practice with respect to manufacture of drug and drug product.   Moreover, within these regulations are sections specifically relating to laboratory controls, and remain a document with which laboratory personnel need to maintain some familiarity.  The CGMP regulations are made available in this pocket guide form for ease of reference by all laboratory personnel, management, and quality assurance staff. It should be noted, however, that the CGMPs are law, which is subject to change, and one should therefore refer to the actual regulations from time to time in order to stay current.  This document is 64 pages in pdf file format. This product is available for download.