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FDA Revises 2006 Guidance: Investigating Out-of-Specification Test Results for Pharmaceutical Production

FDA announces revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Specifically, this revision updates terminology for consistency with current FDA guidance, e.g., quality control unit is changed to quality unit, as well as clarifies concepts related to addressing outlier results, and practices related to the averaging of OOS results.

This guidance provides FDA’s current thinking on how to evaluate OOS test results. For purposes of this guidance document, the term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files, official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications. [FDA]

27

Giu

US frets over pharma supply chain security

The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products...

27

Giu

US FDA - Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

Draft guidance - Submit Comments by 08/23/2022 This guidance describes methods, facility design...

24

Giu

Grindeks amplia la gamma dei generici

Grindeks, azienda farmaceutica degli Stati baltici le cui principali attività sono la ricerca,...

24

Giu

FDA Scorecard: Drug Shortages and Inspections

How has the FDA performed in mitigating drug shortages and in its inspection activity since the COVID-19...

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