FDA, Labelling and Method Validation - Pharmacy Technician Pulse

FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key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. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.

FDA

FDA Documentation Method Validation Packaging

Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

JANUARY 11, 2023

Robbins 1 January 2023 Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification.

Method Validation

Method Validation Documentation Packaging Compounding

Pharmacy Technician Pulse

FDA guidance highlights E&L considerations for ophthalmic drug products

Life-Cycle Approach to Cleaning Topical Drug Products

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