ABSTRACT
Usually, raw materials do not receive the attention that they should. Their identification, quality attributes, and characteristics should be examined and documented early in the development phase and carried out through to commercialization. Why are they so important in the manufacture of a drug product? It is extremely difficult, if not impossible, to manufacture a safe, pure, potent, effective, quality drug product if one start’s out using inferior (or substandard) “building blocks” as materials. One must consider the saying, “garbage in, garbage out.” Controlling the quality of the incoming raw materials will contribute to a higher probability of manufacturing a drug product that meets its quality attributes. Raw materials have been identified as the most common source of endotoxin contamination (1).
