Includes bibliographical references.

Introduction -- General policy -- Quality control-specifications and tests -- Quality control-
international reference materials (International Chemical Reference Substances and Infrared Reference Spectra) -- Quality control national laboratories -- Prequalification of quality control laboratories -- Quality assurance collaboration initiatives -- Quality assurance good manufacturing practices -- Quality assurance-distribution and trade of pharmaceuticals -- Prequalification of priority essential medicines and active pharmaceutical ingredients -- Regulatory guidance -- Nomenclature, terminology and databases -- Summary and recommendations

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent, and practical standards and guidelines for the quality assurance of medicines.