USP Documentary Standards for Biologics

USP’s documentary standards (monographs and general chapters) for biologics are conveyed in the United States Pharmacopeia–National Formulary (USP–NF). Manufacturers of drug products in the U.S. market, including biologics approved under the Public Health Service Act, must conform to any applicable standards published in the USP–NF to avoid being deemed adulterated or misbranded under the U.S. Federal Food, Drug, and Cosmetic Act.

USP–NF features standards, some applicable/enforceable and some informational. Whether a standard is mandatory depends on the requirements detailed in USP–NF General Notices. Generally, requirements in a general chapter do not apply to a particular drug or biologic unless the chapter is called out for application in a particular monograph, or to a class of articles in General Notices.

  • the design, validation, and analysis of bioassays
  • quality attributes of protein A
  • cellular and tissue-based products
  • gene therapy products
  • growth factors and cytokines ancillary materials in cell manufacturing
  • immunogenicity testing
  • bacterial endotoxins
  • sterility testing
  • microbiological and bioburden control
  • injectables
  • supply chain integrity

Before becoming official, generally six months after publication in USP–NF, USP–NF standards go through a public review and comment period during which stakeholders can provide input into USP’s proposed standards. Draft standards are published six times a year in the Pharmacopeial Forum—USP’s free-access, online publication for receiving comments.