Industrial Pharmacy: The Way to Create a Product (Monograph Review)

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Pharmaceutical Chemistry Journal, Vol. 54, No. 5, August, 2020 (Russian Original Vol. 54, No. 5, May, 2020)

REVIEW INDUSTRIAL PHARMACY: THE WAY TO CREATE A PRODUCT (MONOGRAPH REVIEW) S. I. Kolesnikov,1 A. L. Khokhlov,2 A. E. Miroshnikov,2,* and N. O. Pozdnyakov2 Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 5, pp. 62 – 64, May, 2020.

Original article submitted April 5, 2010. The recently published monograph “Industrial Pharmacy: The Way to Create a Product” is devoted to topical problems in this field. The unique interdisciplinary features of drug development require specialists in this industry that possess a high level of qualification and knowledge in many fields such as chemistry, biology, medicine, pharmacy, toxicology, regulatory science, marketing, economics, law, information technology, etc. The monograph presents modern approaches to the implementation of each stage in the creation of a medicinal product: initial search, research and development, production and registration, marketing and sales, and medical use. The monograph highlights the legislative and regulatory documents needed as guides at each stage of the technology cycle. The second part of the monograph provides particular guidelines for technology transfer of drug production and the preparation of industrial production design. Actual significant aspects of many sciences and disciplines and technological processes are collected in one place in this monograph, making it a valuable practical guide. Keywords: industrial pharmacy, medicinal preparations, education, drug development.

The Industrial Pharmacy thrust is urgent because the pharmaceutical industry is a key and vitally important sector of the global economy. The state pays much attention to development of the industrial pharmaceutical sector both to ensure national security and to improve the economic situation because this sector has a high multiplier effect on domestic economic growth in general. The state expresses this interest in the Development Strategy for the RF Pharmaceutical Industry up to 2030, in which the need for import-substitution in the domestic pharmaceutical sector is stated. However, most drugs manufactured in the Russian Federation have already been manufactured for a long time around the world. Several of them have become obsolete. A federal state educational standard of higher education, i.e., Masters of Preparation 33.04.01 “Industrial Pharmacy” (according to Ministry of Education and Science Order No. 1 2 *

705 dated Jul., 26, 2017), has now been developed. This standard is a collection of obligatory requirements for implementing the basic professional higher educational programs, i.e., a Masters program in this field. The list of professional standards corresponding to professional activities of graduates from the Masters program for Industrial Pharmacy includes Specialist in Validation (Qualification) of Pharmaceutical Manufacturing, Specialist in Industrial Pharmacy for Drug Quality Control, and Specialist in Industrial Pharmacy for Drug M