Serialization and Aggregation from a Manufacturing Perspective

BioPharm International, BioPharm International, Regulatory Sourcebook October 2021, Volume 2021 eBook, Issue 4
Pages: 10-13

For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.

Enacted by Congress on Nov. 27, 2013, the US Drug Supply Chain Security Act (DSCSA) is intended to build a more secure supply chain in the United States with the ability to identify and trace drug products and limit exposure to counterfeit, contaminated, and otherwise harmful drugs. Everyone in the pharmaceutical supply chain has had to pivot to meet the DSCSA requirements, including manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Manufacturers, specifically, have had to incorporate serialization into their manufacturing and packaging lines and will eventually also have to incorporate aggregation as well. However, FDA won’t require aggregation compliance until Nov. 27, 2023, which was delayed from 2019.

Read this article in BioPharm International’s October 2021 Regulatory Sourcebook eBook.

About the Author

Meg Rivers is a senior editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.

Article Details

BioPharm International
eBook: Regulatory Sourcebook
October 2021
Pages: 10-13

Citation

When referring to this article, please cite it as M. Rivers, “Serialization and Aggregation from a Manufacturing Perspective," BioPharm International’s Regulatory Sourcebook eBook (October 2021)