TRS 1019 - Annex 1: Procedure for the development of World Health Organization medicines quality assurance guidelines

Overview

The process described in this annex is designed to ensure wide consultation and transparency when developing the World Health Organization (WHO) norms and standards for medicines quality assurance for WHO’s Member States. These quality assurance (QA) guidelines include good practice quality guidelines and regulations (GXPs) and technical regulatory guidance. The steps outlined in Section 3 are designed to ensure that these texts are made available in a timely manner. These QA guidelines are developed and maintained up to date under the aegis of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP), in line with WHO rules and procedures governing expert committees, adopted by WHO Member States.