Quality Attributes of a biologic product have the potential to impact pharmacological properties of a molecule including toxicity, safety and efficacy. It is of utmost importance that proper Critical Quality Attributes (CQAs) are considered during standard setting process of biological products.United States Pharmacopeia (USP) is the oldest Pharmacopeia in the world involved in standard setting process for both chemical and biological Medicines. USP is developing both vertical (monograph) and horizontal (general chapters) standards in the area of biologic medicines. With the advent of Biosimilars, several manufacturers' products will now be available in the market. It is therefore of utmost importance that proper product specific standards are developed to maintain the quality of these products. Recently, USP has launched a new Compendium - Medicines Compendium (MC) in addition to its traditional US Compendium National Formulary (NF).  The MC activities are supported by a global Expert Committee. The members of this committee are from Manufacturers, International standard setting organization and government laboratories. Standard setting process in MC is significantly different from the traditional approach. MC is developing performance based monographs by identifying CQAs of each product and testing multiple manufacturers' products. International reference standards are also being developed to support these monographs.

Standard setting process of biologic products: USP perspective

247th National Meeting (2014)

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