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Setting Specifications and Expiry Dates

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics

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Abstract

Quality Control (QC) release and stability testing of both the API and the final product are part of the overall control strategy employed by a manufacturer to provide assurance of the identity, quality, purity, safety, and potency of the biologic. In this chapter, the central role that QC release and stability testing of the biologic play in the overall control strategy is addressed. Differences between testing requirements for biologics versus chemical drugs will be highlighted. Also, in this chapter, setting scientifically sound and appropriate specifications using a clinical phase-appropriate approach will be examined, including how to justify limits or ranges for four different types of specifications in the market application dossier. Finally, in this chapter, the proper design of a biologic stability program, and the correct interpretation of the stability data, in order to correctly assign the shelf life for a biologic is discussed.

Boundaries aren’t all bad.

That’s why there are walls around mental institutions.

Peggy Noonan, author and columnist for The Wall Street Journal

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    John Geigert

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Geigert, J. (2013). Setting Specifications and Expiry Dates. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-6916-2_11

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