2024 and Method Validation - Pharmacy Technician Pulse

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2024

Method Validation

Endotoxin testing: the international regulatory landscape

European Pharmaceutical Review

APRIL 2, 2024

in the monographs for Water for Injection (0169) and Purified Water (0008) on 1 April 2024. on 1 January 2024. Timely implementation of the reference to USP <86> in the water for injection and purified water monographs is desired to encourage and enable the adoption of these methods for environmental monitoring purposes.

Method Validation

Method Validation Medical Schools

FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

JANUARY 25, 2024

Identification threshold: 10 ppm Qualification threshold: 20 ppm The FDA’s deadline for submitting comments on its draft guidance is 26 February 2024. In the document, the following leachables thresholds were recommended – parts per million (ppm): Reporting threshold: 1 ppm.

FDA

FDA Documentation Method Validation Packaging

Endotoxin testing: the international regulatory landscape

FDA guidance highlights E&L considerations for ophthalmic drug products

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