Seminar "Actual and Safe Technologies for the Production of Active Pharmaceutical Ingredients"
On May 29, 2018, the Ministry of Industry and Trade of the Russian Federation held a training seminar on "Actual and Safe Technologies for the Production of Active Pharmaceutical Ingredients".
The seminar was organized by the Development Department of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation in cooperation with the federal budgetary institution "The State Institute of Medicines and Good Practices" of the Ministry of Industry and Trade of the Russian Federation with the participation of X-TECH company.
The theme of the seminar was chosen not accidentally, as ensuring the production of medicines by native pharmaceutical substances is the key to the stability of the development of the Russian pharmaceutical industry and, as a result, an important factor in ensuring national security of our country.
More than a hundred specialists from leading Russian pharmaceutical companies took active part in the seminar, for which the issues of modern and safe production of API are vitally important.
The welcoming speech was made by Director of the Department of Medical and Pharmaceutical Industry of the Ministry of Industry and Trade of the Russian Federation Alexei Alekhin, the Director of the federal budgetary institution "The State Institute of Medicines and Good Practices" Vladislav Shestakov and the General Director of "X-TECH" Dmitry Polstyanov, who stressed the importance and urgency of the revival of the production of AFI in Russia.
Delivering the welcoming speech, Aleksey Alekhin said: "The issue of medicines safety is becoming especially urgent now, at the time of imposing numerous sanctions against Russia - it seems possible even to introduce earlier unacceptable sanctions related to the field of health care and drug provision.
Taking the circumstances into account and the ever-increasing need for national security, the issue of the revival of the production of active pharmaceutical ingredients in Russia (API) is becoming an urgent and top priority for the development of the national pharmaceutical industry. "
The seminar started with the theme "Regulation of the circulation of Active Pharmaceutical Ingredients". Head of the Department of Regulatory Relations and Good Practices of Federal State Budgetary Educational Institution of Higher Education "Saint-Petersburg State Chemical-Pharmaceutical University" Zakhar Golant spoke about the factors that inhibit the growth of production of API in Russia (competition from India, China, low share of the cost of API in ready-made dosage forms, low availability of raw materials). Also, the state incentive mechanisms for organizing the production of API and existing proposals for improving the investment climate in the area of their production were discussed in detail.
Head of the Department of Good Engineering Practices of the federal budgetary institution "The State Institute of Medicines and Good Practices", Igor Falkovsky, spoke in detail about the main regulatory requirements for safe production and validation of the production processes of Active Pharmaceutical Ingredients. He listed the main requirements to industrial safety, to fire- and explosion safety, as well as to the validation of technological processes in the production of API. Igor conducted a comparison of the requirements of GMP and Russian regulations on fire safety in pharmaceutical production. He provided detailed information on the validation of technological processes in the production of API of various types (chemical, raw vegetable and animal origin, biotechnology), GMP requirements for validation. Also he bring up an issue of the principles of creation and filling of validation documentation.
Frederic Dietrich, General Director of DEC, gave a detailed report on safe production technologies for API. In his speech, issues of explosivity in the handling of powders and organic solvents, mechanisms for the emergence of explosive situations, measures for their prevention were considered; risk of contamination when operating with toxic products; risk analysis for operation with explosive and toxic products.
Particular attention was paid to the safe loading of powders into a hot reactor with organic solvents. A risk analysis was carried out using various loading methods into vessels - from manual loading to the ultra-modern and absolutely safe PTS system, the advantages of using Isolator systems in comparison with other existing methods are given.
Modern equipment for safe operation with powders and organic solvents was presented, examples of the operation of such equipment at well-known pharmaceutical enterprises are given.
Dmitry Polstyanov, General Director of X-TECH, continued the theme of Frederick Dietrich's speech about the safe work with highly toxic products and discussed in detail the issues of washing, cleaning and, in particular, issues of operator protection.
In his speech, Dmitry listed the criteria for selecting equipment for working with toxic substances (in terms of the possibility of isolating the process, the possibility of automatic cleaning, safe replacement of components, the necessary level of automation) and discussed with colleagues various types of pharmaceutical equipment (reactors, filter dryers, centrifuges) from the standpoint of safety, efficiency and reduction of production costs.
Director of the development and transfer of technology Department of R-Pharm company Alexei Smirnov, devoted his report to the issue of technology transfer for the production of API. During the speech Alexey discussed with his colleagues all the stages of the transfer process of the API production, such as: decision-making on transfer, risk identification, risk analysis, development and coordination of the transfer plan; preparation of a production protocol, a technological instruction, a validation protocol, a draft budget; materials necessary for the preparation of the transfer dossier and in the end - the transfer report. Participants of the seminar, previously unfamiliar with the technology transfer process, after Alexei Smirnov's report received a clear idea of the necessary stages of the transfer in its implementation.
All the themes raised during this seminar will help representatives of Russian pharmaceutical companies understand the importance of restoring the production of API in the Russian Federation, as well as determine the choice of modern, safe and cost-effective equipment for its production.