PHARMACEUTICAL MICROBIOLOGY - V. A. Galynkin - 2015

Preface to the Second Edition

15 years have passed since we first conceived the idea of writing the country's first specialized textbook on pharmaceutical microbiology. This initiative was prompted by the fact that the educational literature recommended by the Ministry of Health of Russia for students of pharmacy universities covered pharmaceutical microbiology in a mere 5-page section entitled “Microflora of Herbal Medicinal Raw Materials, Phytopathogenic Microorganisms, and Microbiological Quality Control of Medicines.” This was clearly insufficient to convey the practical Goals and Objectives of pharmaceutical MICROBIOLOGY AS A progressive, applied discipline spanning various aspects of modern pharmacy.

Years of teaching experience in medical and pharmaceutical universities convinced us of the need to establish pharmaceutical microbiology as an independent discipline and update all of its core sections. However, the creative enthusiasm of the authors—faculty members of the I.M. Sechenov First Moscow State Medical University and the Saint Petersburg State Chemical and Pharmaceutical Academy—was significantly constrained by the absence of a dedicated curriculum for pharmaceutical microbiology, which is a prerequisite for publishing state-funded textbooks. The approval process for federal and departmental textbooks is lengthy and does not always guarantee success for authors. Given these circumstances, we decided to undertake this project independently and within a short timeframe.

In 2003, the Arnebia Publishing House (Moscow) published the first edition of Pharmaceutical Microbiology in a print run of 1,000 copies. The book featured up-to-date material on the most prominent Applications of pharmaceutical microbiology: the development, manufacturing, and quality control of medicinal products. Over time, the book became the cornerstone of a thematic series of publications, as it was supplemented with a Glossary of terms, a guide to Research Methods, a handbook on culture media, and various study guides. These resources continuously updated the core textbook over the span of a decade.

The initiative to prepare the second edition of Pharmaceutical Microbiology was driven by significant Changes in the domestic drug Circulation sector and the strengthening of the regulatory framework. In July 2015, Federal Law No. 429-FZ of the Russian Federation dated December 22, 2014, "On Amendments to the Federal Law 'On the Circulation of Medicines'," entered into force. Furthermore, the milestones of the "Strategy for The Development of the Pharmaceutical Industry of the Russian Federation for the Period up to 2020" and the "Strategy for Drug Provision to the Population of the Russian Federation up to 2025" are being actively implemented.

The professional education standards for pharmaceutical industry specialists have risen noticeably. The harmonization of Russian standards for drug research and manufacturing with international requirements has been initiated, and a significant number of European pharmaceutical companies have established industrial production facilities for medicinal products within the Russian Federation. All these factors were taken into account in preparing the second edition of Pharmaceutical Microbiology.

As this publishing project comes to completion, we consider it our duty to express our gratitude to Professor N. A. Zaikina and Associate Professor T. S. Potekhina for their active participation in writing the first book and other collaborative thematic publications. We are also indebted to Professors N. D. Bunyatyan and T. F. Odegova, as well as Doctor of Pharmaceutical Sciences O. V. Gunar, for their expert consultation and professional support. Finally, we express our sincere appreciation to the publishers, represented by S. A. Rabinovich and S. O. Serebryakov, for their expertise and assistance in bringing this project to life.

The objective of this book is to introduce students of pharmaceutical, medical, and biotechnological universities, as well as professionals working in the field of drug circulation, to the Current state of development and Structure/182.html">Practical Application of pharmaceutical microbiology in the Russian Federation.

We hope that the second edition of Pharmaceutical Microbiology will not only meet the needs of students but also serve as an accessible resource for the postgraduate education of retail pharmacists, pharmaceutical manufacturing technologists, and quality control laboratory microbiologists.

Class="right">Professor V. A. Galynkin, Professor V. I. Kocherovets