Presentation of a new book at the II All-Russian GMP Conference
On September 19, in the framework of the II All-Russian GMP conference Second Day opening, a presentation of the book «What is good and what is bad in pharmaceutical production» will take place. Authors of the manual – V. Shestakov, Director of FSI “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade of the Russian Federation and Yu. Podpruzhnikov, Ph.D., Professor, National Pharmaceutical University, Department of Quality Management (Ukraine) in a discussion format will tell about the current issues of the book content.
The first publication copies will be available for public during the conference. This book is intended for students and professors of pharmaceutical colleges, pharmaceutical faculties of institutes, universities, other universities and faculties for advanced training of pharmacy workers. The monograph can serve not only as a textbook, but also as a manual for professionals of the pharmaceutical field. In addition, it may be of interest to a wide range of health professionals, as well as patients who show great interest in the quality of medicines.
The publication addresses topical issues of ensuring the quality of medicines in the process of their industrial production within the framework of a common system of appropriate pharmaceutical practices covering all stages of the medicines circulation. The content of the current rules of Good Manufacturing Practice has been characterized, as well as an analysis of future changes and trends in the development of these rules has been conducted. Regulatory mechanisms in the sphere of medicinal products circulation have been analyzed. Particular attention has been paid to the analysis of violations detected in the process of GMP-inspection, the results of inspections, which were carried out by regulatory authorities of different countries, have been summarized.
Leading industry experts expressed a high opinion to the publication:
«Now we can confidently say that currently GMP is not a sacral knowledge of a single category of specialists. The book “What is good and what is bad in pharmaceutical production” makes these rules accessible and will be useful for everyone without exception – as a textbook, as a reference book, as an interesting reading for those who work in the pharmaceutical industry and keeps an eye on the pulse in matters of quality and good practices”. S.A. Tsyb, Deputy Minister of Industry and Trade of the Russian Federation.
«The book contains unique material on the analysis of the results of inspection of pharmaceutical productions of medicines in different countries and groups of countries applying the rules of Good Practices adopted in these countries. Discussion, analysis and generalization of the observations of GMP inspectors opens the possibility for the interested reader, together with the authors, to get into the practice of implementing GMP rules and other good practices». I.A. Narkevich, Rector of SPHFA, Doctor of Pharmaceutical Sciences, Professor.
«The monograph “What is Good and What is Bad in Pharmaceutical Production» is not just a textbook on good practices. This is a profound, meaningful analysis of the whole quality control system – not only from the dry theory point of view, but with application of the Russian GMP inspectorate practice, which for the first year and a half of its work has shown a confident result and firmly established itself in the professional international environment as a guarantee of medicines production quality”. R.U. Khabriev, Vice-Rector of the Russian State Medical University (RGMU), Academician of RAN, Doctor of Medical Sciences, Doctor of Pharmaceutical Sciences, Professor.
The book was published with the support of the group of companies “GEROPHARM” and the pharmaceutical company OBL Pharm (FP «Obolenskoe»).
- The workshop «Risk analysis in planning of validation at pharmaceutical manufacture»
- Fifty experts of the pharmaceutical industry took part in the the expert-advisory workshop «Requirements and application of GMP rules for API manufacture»
- A meeting with the professor of the Sechenov University was held in the State Institute of Drugs and Good Practices
- A meeting of the Council for Professional Qualification in Pharmacy was held in Moscow
- SID & GP – being ahead of time