The Compliance with the New USP <665> and <1665> Chapters for Drug Manufacturing Items Evaluation

Davide Tartaglione, Regulatory Consulting, Eurofins Regulatory & Consulting Services Italy, Vimodrone, Italy (DavideTartaglione@eurofins.com)

The impact of the compounds released in the product during the manufacturing process could represent a dangerous matter of their intrinsic toxicity on the patients and a chemical impact that could affect the potency of the drugs. E&L testing of the Single or Multiple Use System (SUS, MUS) used in Biologics and Drug manufacturing should be design by following the suggestions of the USP<1663> and <1664> chapters and applying, when possible, a standardized E&L protocol defined by the BioPhorum Organization Group (BPOG).

In May 2022, USP published the new chapters <665> and <1665> which define the Design of the Experiment for these in-process items and constitute a standard for E&L testing. Drug manufacturer companies need to be aligned in terms of risk assessment and analytical strategy. The presentation will focus on the analytical steps of the USP <665> and the variables to define the testing together with case studies relevant to the industry.

During the presentation USP <665>  vill be examined by detailing a standard assessment and testing approach for qualification of plastic components and systems used in drug manufacturing. This presentation will provide valid insights  for a successful transition to the new USP <665> extractables testing standard.

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Short Biography of Presenting Author

Davide Tartaglione

Davide graduated in Biology applied to Biomedical research in Milan and joined Eurofins where he worked for 6 years as a Project Manager. He then joined the Pharmaceutical industry, being part of a consultancy firm and strengthening his expertise in Process validation and Extractable & Leachables. After an experience in a Contract Manufacturing Organization, supporting customers in commercial manufacturing of Drug products and Biologics, he joined back Eurofins BioPharma Product Testing in Italy in 2019. Currently is covering the role of Senior Consultant, leading and managing a team of experts in the Pharmaceutical area.