WHO Releases Draft Update of Stability Testing Guidelines

The World Health Organization has released a draft update to its guidelines for API and finished drug stability testing that says it reflects how stability testing has evolved since the release of the original in 2009.

Under the updated draft, each product must undergo stability tracking throughout its shelf-life to ensure it remains compliant with the label’s specified storage conditions and the stability program should include at least one batch of product manufactured in every strength and every container closure system annually, unless otherwise justified.

The WHO also updated the guidance to better reflect stability testing requirements for generics.