The World Health Organization is revising its guidance to industry on good manufacturing practices for investigational drug products, including new recommendations for quality risk management.
The draft working document, which was released in November 2020, is open for public comment until 6 January 2021. The draft is expected to be revised and go through a second round of public comment before being presented to the WHO’s Expert Committee on Specifications for Pharmaceutical Preparations in late 2021. The draft guideline is an update to recommendations issued by WHO in 1996.
The guideline update comes at the request of the WHO’s Prequalification Team – Inspections Services, in part to account for new manufacturing situations arising from the production of COVID-19 therapeutics.
“The objective of this update is to bring the guideline in line with current expectations and trends in good manufacturing practices and to harmonize the text with the principles from other related international guidelines,” according to the WHO draft guideline…