GMP grade

A supplier's designation for reagents, media, enzymes, plasmids or other materials made and tested under controls intended for use in GMP manufacturing, as opposed to research grade. Compared with research grade, the differences usually lie in origin documentation, traceability, microbial and endotoxin control and tighter specifications. The label on its own does not tell you which standard the supplier applies, so ask for the certificate of analysis, the quality agreement terms and origin statements. For materials of animal or human origin used in products for Japan, the origin statement must support conformity with Japan's Standard for Biological Ingredients, which also covers culture medium components and additives.