TY - BOOK ED - World Health Organization TI - Who Expert Committee on Specifications for Pharmaceutical Preparations : : forty-seventh report SN - 9789241209816 AV - RS189 .W67 2013 PY - 2013/// CY - Geneva PB - World Health Organization KW - DRUG FORMS + DOSAGE FORMS (PHARMACY) KW - Drugs Quality control N1 - Introduction General policy Quality control: specifications and tests Quality control: international reference materials (International Chemical Reference Substances and International Infrared Reference Spectra) Quality control: national laboratories Quality assurance: good manufacturing practices Quality assurance: new approaches Quality assurance: distribution and trade of pharmaceuticals Prequalification of priority essential medicines including active pharmaceutical ingredients Prequalification of active pharmaceutical ingredients Prequalification of quality control laboratories Regulatory guidance Nomenclature, terminology and databases Miscellaneous Summary and recommendations Annexes ER -