Разработка и регистрация лекарственных средств (Jan 2019)

THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURE

  • S. A. Zaitsev,
  • A. V. Basevich,
  • A. O. Hrustaleva

Journal volume & issue
Vol. 0, no. 1
pp. 208 – 214

Abstract

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The paper demonstrates application of the newly developed procedure for pre-selection of suppliers of active pharmaceutical ingredient to manufacture of drugs using the tools of risk analysis. The procedure allows to organize the process of selecting suppliers, to reduce the risk of acquiring the substance non-pharmacopoeia quality, to minimize the consumption of cost, time and manpower resources for qualifying manufacturers, to form a reasonable list of manufacturers to audit their production sites.

Keywords