International – WHO recommends risk management plans for high-risk excipients

The World Health Organization (WHO) has released two draft appendices to a recent draft guideline on good manufacturing practices (GMPs) for excipients. The first document recommends manufacturers develop risk management plans for controlling and preventing contamination of high-risk excipients. A separate appendix lists the types of high-risk excipients that should be subject to scrutiny under these plans.

Both documents complement a draft guideline issued by WHO last year on controlling excipients. (RELATED: WHO proposes updated excipient GMPs in wake of contaminated cough syrupRegulatory Focus 10 April 2023)

These documents follow a health alert issued by WHO in January 2023 linking at least 300 child deaths in Gambia, Uzbekistan, and Indonesia following ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG)…