What do GMP, ISO and QSR mean, and how do they differ?
A – GMP stands for Good Manufacturing Practices, and refers to a system of manufacturing that guarantees reproducibility of product quality to set specifications. The requirements differ depending on what type of product is being manufactured and whether it is for pharmaceutical or diagnostic purposes. ISO stands for International Standards Organization, which offers a standard for operating a firm from management through manufacturing. It is more encompassing than GMP. QSR stands for Quality Systems Regulation, which are GMP standards described by the FDA for the manufacture of product for the diagnostic industry. These are very specific guidelines on how a quality system that is certifiable by the FDA must be designed. They differ very little in many ways. Both the ISO and QSR systems describe GMP standards. The ISO system pays more attention to the management of the firm and places a number of reporting loops in the firm to ensure attention to issues. In a well run company this is d
