1. Introduction -- 2. General policy -- 3. Quality control – specifications and tests -- 4. Quality control – international reference materials (International Chemical Reference Substances and Infrared Reference Spectra) -- 5. Quality control – national laboratories -- 6. Quality assurance – good manufacturing practices -- 7. Quality assurance – new initiatives -- 8. Quality assurance – distribution and trade of pharmaceuticals -- 9. Prequalification of priority essential medicines -- 10. Prequalification of active pharmaceutical ingredients -- 11. Prequalification of quality control laboratories -- 12. Regulatory guidance -- 13. Nomenclature, terminology and databases -- 14. Miscellaneous -- 15. Summary and recommendations.

The WHO Technical Report Series makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects. Members of such expert groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily reflect the decisions or the stated policy of WHO.

https://iris.who.int/bitstream/handle/10665/176954/9789240693968_eng.pdf?sequence=1