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FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

FDA 98
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Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification.