ABSTRACT
The role of the United States Pharmacopeia (USP) in the microbiological assessment of parenteral manufacturing is comprehensive as well as being very diversified. It is part of the microbiological continuum assessment that starts in the development of the product and continues through the stability of the product once it has reached the distributor and the patient. The microbiological assessment continuum starts with raw ingredients, excipients, drug substances, manufacturing, aseptic processing or terminal sterilization, and preservation of products during storage as well as maintenance of sterility. At every level in the continuum, USP has a monograph, several general chapters, and some information chapters that are to be used critically to ensure the microbiological quality of the final product.
