WHO plans to tighten excipient GMPs after deaths

Faced with another series of child deaths linked to contaminated cough syrup, the World Health Organization (WHO) is proposing to update its good manufacturing practice (GMP) guidance for excipients.

There have been a spate of recent incidents in which substandard cough syrup products have resulted in hundreds of infant fatalities – in Uzbekistan, Gambia and Indonesia – as a result of the use of excipients, including glycerin, that were contaminated with diethylene glycol and/or ethylene glycol.

The draft guideline - WHO good manufacturing practices for excipients used in pharmaceutical products – covers the production, control, storage and distribution of excipients and is open for comments until May 21. It is the first major update on excipient GMPs in more than two decades.

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