WHO Draft GMP for IMPs and Good Practices for R&D

The World Health Organization (WHO) has issued a draft revision for comment of its good manufacturing practices (GMP) guideline for investigational medicinal products (IMPs) and a separate new draft guideline on “Good practices for research and development facilities”. Comments on both drafts should be sent to the WHO by January 6, 2021. These proposed changes are a consequence of the COVID-19 pandemic and recommended by WHO’s Prequalification Inspection Team.

WHO said that the objective of the GMP update is to align the guideline with “current expectations and trends in GMPs” and to “harmonize the text with the principles from other related international guidelines”.

The guideline for R&D facilities is a response to the “unprecedented fast development” of COVID-19 treatments as currently there are no regulatory guidelines which propose extending GMP principles to R&D facilities, while the data collected from these batches influence the product’s stability, process validation, and analytical methods development. WHO say that the industry should “encourage science-based and risk-based approaches in product research and development”.

Both of these draft documents can be found in the WHO section of Legislation & Guidance on the NSF Pharma app.