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The Art of Setting Specifications

  • John Geigert
Chapter

Abstract

Biopharmaceutical drug substance and drug product release and stability testing, typically performed by Quality Control, is an essential part of the overall control strategy employed by a manufacturer to provide assurance of their product’s identity, purity, quality, potency, and safety. Each test method performed has an assigned limit or boundary, or descriptor, referred to as specification. In this chapter, the challenge of setting specifications for a biopharmaceutical, using a risk-based approach during clinical development and a formal justification when seeking market approval, will be examined.

Keywords

Specifications Release Shelf life Risk-based Clinical development Justification Commercial Biosimilars 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • John Geigert
    • 1
  1. 1.BioPharmaceutical Quality SolutionsCarlsbadUSA

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