The World Health Organization (WHO) has issued the proposed guidance, Guideline for the Production and Control of Specified Starting Materials. The document focuses on those materials used as or in the production of active pharmaceutical ingredients (APIs) and aims to offer a global approach to defining quality. The guidance details quality levels for some materials and states that for others a risk assessment, considering such factors as the number and nature of synthesis steps, may be suitable. Comments on the document can be submitted until 1 May and those received by 23 April could be discussed at the consultation on paediatrics and generic guideline development. The draft guideline can be found at ".