TRS 957 - Annex 3: WHO good manufacturing practices for pharmaceutical products containing hazardous substances

Overview

These guidelines set out good practices applicable to facilities handling pharmaceutical products (including active pharmaceutical ingredients (APIs)) that contain hazardous substances such as certain hormones, steroids or cytotoxins. They do not replace national legislation for protection of the environment and personnel. Other WHO guides to good manufacturing practices (GMP) and regulations need to be observed in addition to the workers’ safety criteria (1–4).