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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Draft guidance - Submit Comments by 08/23/2022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 elements, and controls that are important in preventing drugs  from being cross-contaminated with compounds containing a beta-lactam ring.   This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of non-penicillin beta-lactam antibacterial drugs and non-antibacterial beta-lactam compounds.   

This guidance recommends complete and comprehensive separation  of the manufacturing operations of non-penicillin beta-lactam antibacterial drugs from the manufacturing operations of other drugs.  For manufacturers of non-antibacterial beta-lactam compounds, this guidance provides recommendations on cross-contamination prevention strategies, including examples of relevant design features and control approaches for those seeking to justify a cross-contamination prevention strategy other than complete and comprehensive separation when appropriate. [FDA]

05

Ago

EMA publishes revised implementing rules, explanatory note for fees payable to agency

The European Medicines Agency (EMA) has published revised rules for the implementation of the fees payable...

02

Ago

AIFA - Online le istruzioni aggiornate per la nomima dell'amministratore utenze aziendali (AUA)

L'aggiornamento riguarda il nuovo indirizzo AIFA a cui inviare il modulo con cui il legale rappresentante...

01

Ago

Sterling, Fsi sottoscrive il 35% del capitale del gruppo farmaceutico

Sterling e Fsi annunciano la sottoscrizione di un contratto vincolante per una partnership...

01

Ago

Shopping per Alfasigma, accordo per il 100% di Sofar

Un altro colpaccio in questa estate calda per il pharma. Alfasigma si rafforza nel ‘gastro’...

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