ISPE EAEU
Conference - 2023
The main goal of the Conference is an open discussion of technical and technological innovations in the field of pharmaceutical production, the latest regulatory trends and their implementation.
Leading experts of the pharmaceutical industry, representatives of government authorities and professional associations, manufacturing companies from the EAEU and other countries are invited.
The ISPE Eurasian Partner Conference was held with the support of the Ministry of Industry and Trade of the Russian Federation in Moscow on November 16-18, 2021. The event took place in a hybrid format.
About 200 participants from 78 companies took part in the Сonference. 34 speakers made presentations at 7 thematic sessions dedicated to updating the ISPE Guidelines for 2020-2021. and issues of international integration of the professional pharmaceutical community of Russia and the EAEU; contract manufacturing (quality management and compliance); harmonization of requirements for the production of medicines; pharmaceutical engineering and design; digitalization of the pharmaceutical industry.
In addition, some participants were given a unique opportunity to visit the plants of the Kaluga Region Pharmaceutical Cluster.
On November 16, the “ISPE Regulatory Updates over 2020-2021” session will be held within the framework of the ISPE EAEU Annual Conference.
The International Society for Pharmaceutical Engineering (ISPE) regularly conducts issue-related surveys among pharmaceutical specialists, the results of which then serve as the basis for relevant guidance documents. Thus, in February 2021, the Task Team held a survey on Quality Risk Management (QRM) and Knowledge Management (KM). According to the survey, pharmaceutical companies have been slow in integrating Quality Risk Management with Knowledge Management. To better integrate QRM and KM, a Risk-Knowledge Infinity Cycle (RKI Cycle) structure has been proposed that can be applied throughout the entire product lifecycle. And according to this survey, implementing a structure such as the RKI cycle to better combine QRM and KM can bring a number of significant benefits, including better risk-based decisions and better control strategies.
The February survey results served as the basis for RKI Cycle structure development and together they gave rise to a publication (May 2021) of the Good Practice Guide: Knowledge Management in the Pharmaceutical Industry), which focuses on how KM can enable a more effective PQS.
Based on examples from other industries, where knowledge management programs have already been implemented and are efficiently functioning as part of routine business processes, and taking into account an insignificant practical application of the program in pharmaceutical industries, the Guide proves that the symbiosis of knowledge management and risk management can enhance nearly every element of the PQS across the product lifecycle. Beyond the PQS, substantial and compelling benefits of effective KM include improved business performance as a whole through effective decision-making based on risk assessment, build more robust processes, enhance workforce involvement.
This and other provisions of the ISPE Guide will be presented in November 16 by Nuala F. Calnan, founder of Biopharm Excel Ltd, a company specialized in biopharmaceutical innovations. The report will be presented within the Annual conference of the ISPE Eurasia Affiliate to be held in Moscow on November 16-18. Register now. And if you can’t take part in face-to-face format, but want to learn about latest developments in the ISPE Guidance Documents, get registered to participate online!
On November 16-18, within the framework of the ISPE EAEU Annual Conference, a session will be held dedicated to an overview of updates to ISPE Guidance Documents over 2020-2021.
A distinctive feature and key advantage of ISPE membership is access to up-to-date guides and even the opportunity to participate in the preparation of documents that explain in detail the practical application of norms and regulations of regulatory bodies concerning proper manufacture of medicines. Moreover, ISPE Guides often serve as reference to GMP inspectors, who regard them as a collection of comments and clarifications on the main FDA and EMA regulations. Unfortunately, most of the Guides, especially the new ones, are written and available in English only. Therefore, for the second year in a row, the ISPE Eurasia Affiliate, following the requests of pharma representatives in the Eurasian space, selects the most popular Guides and presents their key provisions through expert case studies at industry conferences and provides recommendations on the use of such Guides so that to enhance manufacturing processes at pharmaceutical enterprises.
On November 16, during thesession “Overview of ISPE Guidelines Updates as of 2020-2021”, GMP expert consultants and pharmaceutical manufacturers which already implement ISPE Guides in their routine operations, will present 4 Guides. In particular, Head of the VIALEK International Training Center, Alexander Alexandrov, will present the APQ Guide: Corrective Action & Preventive Action (CAPA) System, which is the first in the planned four-part series that seeks to improve the pharmaceutical quality management system within ISPE’s initiative “Advancing Pharmaceutical Quality” (APQ). Pharmacy practitioners as well as scientific community, specialized associations and regulators were actively involved in the process of Guide preparation and quality metrics development. As noted by one of Guide’s authors, Senior Director of Corporate Quality Systems and Cultural Excellence at Perrigo Tami J. Frederik, the Guide is structured according to the principle “Assess – Aspire/Advance – Act – Progress” and contains the practice of applying APQ in the CAPA system by assessing the CAPA documentation, identifying problems and their root causes, corrective and preventive actions, CAPA efficiency and performance indicators. This Guide shall contribute to enhancing the CAPA system quality in pharmaceutical companies to ensure a continuous supply of high quality medicines to patients.
The Advancing Pharmaceutical Quality (APQ) program is based on the ICH Q10 Pharmaceutical Quality System (PQS) model. The program is aligned with international initiatives that promote quality excellence and serves as a response to FDA’s request stated in the Drug Shortage Report as of 2019.
In addition to this Guide, the ISPE EAEU Annual Conference participants will be also informed about the release of translated ISPE “Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)». It is available in Russian from July 2021.
Have time to register to the ISPE Eurasian Affiliate conference, which will be held in Moscow on November 16-18. And if you can’t take part in face-to-face format, but want to learn about latest developments in the ISPE Guidance Documents, get registered to participate online!
On 16 November, within the framework of the ISPE EAEU Annual Conference, a session on OEM manufacturing will be held, where leading national experts will discuss the current trends in quality management and ensuring compliance with GxP global standards.
OEM manufacturing in the pharmaceutical industry is not only a trend derived from the “third wheel” rule or the need to localise a product in Russia; it is also the regular life of many national pharmaceutical companies comprised of more than one plant. The most striking example of OEM manufacturing today is production of COVID-19 vaccines.
How do developers choose the site where the industrial production of today’s most in-demand product will be launched? What does the OEM site pay attention to when signing a contract for technology or production transfer? What is the responsibility of the marketing authorisation holder in terms of complying with good manufacturing practices, and what role does a quality agreement between the customer and the OEM play in ensuring compliance with these practices? These and related issues will be highlighted by speakers at the panel session “OEM Manufacturing: Quality Management and Compliance.”
The quality of a medicine produced under a contract depends not only on the manufacturing process. For example, Tatiana Vyazmina, Quality Director of R-Pharm Group, notes that the manufacturer and the customer start their interaction at the stages preceding production, and continue to interact in the course of such production and even during further medicine commerce. Tatyana Vyazmina emphasises: “The quality of a medicine produced under a contract depends on the detailed and extensive nature of responsibilities enforceable by each of the parties in relation to quality assurance issues and on compliance with the GMP principles at each stage of production.” At the same time, as Faiza Yagudina, Quality Director of AKRIKHIN JSC, emphasises that at the preparatory stage preceding production, it is important to formalise in the quality agreement the partner relationship between the customer and the OEM site, which will ensure further efficient cooperation and interaction.
“For the first time, we have managed to assemble such a strong line-up of speakers who have colossal experience in production in terms of quality assurance. They are: Tatyana Vyazmina, our partner from R-Pharm, well-known and beloved by everyone in the pharmaceutical market; Faiza Yagudina from AKRIKHIN, who knows all manufacturing aspects from the first-hand experience; Olga Solovyeva from LegisPharm, who will share with the Conference audience the main requirements in terms of GM(D)P – responsibility of marketing authorisation holders.
Alexey Kovrigin from Valenta Pharmaceuticals, one of the candidates to the Board of Directors of the ISPE Eurasia Affiliate, will also take part in the session,” Vladimir Orlov, the session moderator, ISPE EAEU Director said.
The ISPE EAEU Annual Conference will be held on 16-18 November in Moscow in a hybrid format. The general partner of the event is Skopin Pharmaceutical Plant (Ryazan), the main strategic partner is R-Pharm Group, which consolidates 9 high-tech industries and 70 branches in 30 countries. Traditionally, the special partner of the event is the Russian branch of bioMérieux – bioMérieux Rus LLC. The Conference will be held with the support of X-TECH – supplier of equipment and complex solutions for pharmaceutical enterprises, POLYSAN, AKRIKHIN and Valenta Pharm pharmaceutical companies, AbbVie biopharmaceutical company. Among the Conference 2021 partners is LegisPharm company, specialized in preparation, filing and maintenance of dossiers for medicines and medical devices.
It is the second year in a row that bioMérieux Rus LLC – the official representative in Russia of France’s bioMérieux SA that holds leadership in laboratory diagnostics and microbiology – will serve as the special partner of ISPE EAEU conference. bioMérieux’s solutions have been available in Russia for 25 years already. The list of bioMérieux’s customers includes Russian and foreign pharmaceutical manufacturers who own manufacturing facilities and carry out microbiological quality control of the manufacturing process and products from environmental monitoring to sterility testing and microbial identification up to a species. The company offers solutions in the following groups: equipment, reagents, software and customer support by the local licenced customer service and competent product specialists.
Skopin Pharmaceutical Plant supports the conference of the Eurasian ISPE Affiliate, which will be held on November 16-18 in Moscow.
“At present, the company is revamping the existing areas to manufacture unique medicines using technologies of leading foreign pharmaceutical companies, as well as simultaneously building new facilities to manufacture cytostatic drugs and liquid dosage forms. Therefore, the engineering issues and good practices, participation in discussions and exchange of experience with the best experts having worked in leading inspectorates and regulatory bodies of Europe and the United States, and meeting with Eurasian inspectors is an opportunity to take and implement only the best GxP-practices, to take preventive measures against the risks that lie in wait for any pharmaceutical manufacturer revamping its plant,” – this is how General Director of Skopinpharm Inga Nizharadze explained the support provided to the conference by the company. – We are also interested in the OEM manufacturing, since Skopinpharm is actively working on technology transfer associated with a variety of medicines of international pharmaceutical companies. We act as an OEM site for Novartis, Octapharma, CSL Behring, Aspen, etc.”
Skopinpharm today is a modern, rapidly developing pharmaceutical company, manufacturing 55 types of products in accordance with GMP Rules. It produces all types of solid and liquid dosage forms, prefilled syringes and lyophilisates. For example, the pill production output exceeds 1.2 billion pills per annum, and the blood product output is over 500 thousand units per year.
The company actively participates in implementing the program of import substitution of medicines for cancer treatment. In October 2021, Skopinpharm signed SPIC 2.0 to introduce state-of-the-art technologies for the manufacture of unique cytostatic drugs, protein kinase inhibitors and diagnostic systems for tumor tissues imaging at early disease stages.
“At present, the company is revamping the existing areas to manufacture unique medicines using technologies of leading foreign pharmaceutical companies, as well as simultaneously building new facilities to manufacture cytostatic drugs and liquid dosage forms. Therefore, the engineering issues and good practices, participation in discussions and exchange of experience with the best experts having worked in leading inspectorates and regulatory bodies of Europe and the United States, and meeting with Eurasian inspectors is an opportunity to take and implement only the best GxP-practices, to take preventive measures against the risks that lie in wait for any pharmaceutical manufacturer revamping its plant,” – this is how General Director of Skopinpharm Inga Nizharadze explained the support provided to the conference by the company. – We are also interested in the OEM manufacturing, since Skopinpharm is actively working on technology transfer associated with a variety of medicines of international pharmaceutical companies. We act as an OEM site for Novartis, Octapharma, CSL Behring, Aspen, etc.”
Skopinpharm today is a modern, rapidly developing pharmaceutical company, manufacturing 55 types of products in accordance with GMP Rules. It produces all types of solid and liquid dosage forms, prefilled syringes and lyophilisates. For example, the pill production output exceeds 1.2 billion pills per annum, and the blood product output is over 500 thousand units per year.
The company actively participates in implementing the program of import substitution of medicines for cancer treatment. In October 2021, Skopinpharm signed SPIC 2.0 to introduce state-of-the-art technologies for the manufacture of unique cytostatic drugs, protein kinase inhibitors and diagnostic systems for tumor tissues imaging at early disease stages.
“Since 2019, we have been cooperating with the International Society for Pharmaceutical Engineering.” With our support and active participation of R-Pharm specialists, the Russian association has received the status of a Eurasia Affiliate; this year, with the support of our colleagues from the Society, we have presented the result of the long-term work – the Russian translation of the ISPE manual “Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)”. Being theISPE EAEU partner, R-Pharm is engaged in the business programme development process. Over the 20 years, we have gained experience not only in quality issues and quality management, but also in establishing OEM manufacturing enterprises and joint ventures. We will present this experience during the session “OEM Manufacturing: Quality Management and Compliance,” – Tatiana Vyazmina, Quality Director of R-Pharm Group said.
R-Pharm Group has 9 high-tech production facilities and 70 branches in 30 countries with over 5 000 employees. The Company’s portfolio includes more than 20 science-intensive products, many of which can significantly contribute to future fighting against socially significant diseases.
The scientific and technological pharmaceutical company POLYSAN LTD, a successful pharmaceutical firm with a strong scientific base and in-house high-tech production capabilities, acts as a partner of the ISPE EAEU Annual Conference session devoted to pharmaceutical engineering.
The pharmaceutical plant of POLYSAN produces more than 26 million packs of drugs annually. A significant part of the company’s product range is included in the VED list. The company produces 4 original drugs: Cycloferon (has antiviral, immunomodulatory, antiphlogistic action), Cytoflavin (intended for treatment of brain dysfunctions and improvement of cerebral blood flow), Reamberin (prevents exogenous and endogenous intoxication of various etiologies) and Remaxol (comprehensive treatment of liver diseases).
The company’s products are sold in Russia, the CIS countries, Southeast Asia, Latin America and Mongolia. POLYSAN implements localisation projects aimed at production of drugs of international concerns like Stada, Bayer and Pfizer.
POLYSAN’s own production plant was commissioned in 2005 in Frunzensky district of St. Petersburg. The second stage of the production plant, a modern warehouse and an in-house power supply facility were constructed in 2012. In 2016, POLYSAN launched a large investment project aimed at reconstruction of production facilities, modernisation of the power supply facility, expansion of the warehouse space and construction of a new scientific and technological centre. The third stage of the production plant was commissioned on 28 November 2018. Construction of the POLYSAN’s scientific and technological centre started in 2017. It was opened in November 2019.
In January 2017, the project for reconstruction of production facilities of the pharmaceutical plant of POLYSAN was recognised as a strategic investment project of St. Petersburg, and POLYSAN as a strategic investor of St. Petersburg by the Decision of the Government of St. Petersburg.
At the end of September 2021, the company launched Sputnik V and Sputnik Light COVID-19 vaccines production line. It became possible due to the signing of the Memorandum on the Development of Pharmaceutical Production in St. Petersburg between POLYSAN and BIOCAD on 3 June 2021 within the framework of SPIEF’21 (St. Petersburg International Economic Forum). Sputnik V and Sputnik Light vaccines will be produced within the framework of the Agreement signed, both parties to which are involved in the full-cycle vaccine production process.
The project implementation required a large-scale modernisation of the existing production facilities of POLYSAN LTD: within a short period of time the company installed the cold chain equipment for aseptic bottling of drugs, arranged conditions for the storage of drugs requiring low temperatures (up to -30 degrees), designed and installed the equipment for the production and bottling of Sputnik V and Sputnik Light vaccines, as well as immunobiologicals. The capacity of the POLYSAN’s new production line is up to 40 million doses of vaccine per year.
POLYSAN’s main principle is to put all efforts, all its scientific resources in the development and production of effective and reliable drugs. POLYSAN: intelligence on guard of health.
X-TECH acts as a partner of the ISPE Annual Conference session devoted to harmonisation of drug production requirements.
X-TECH specialises in comprehensive solutions for the design, supply and commissioning of equipment and production lines. The company’s employees help customers reduce the period of time from origination of the idea to project implementation, find the required technology, introduce it into production and ensure optimisation or scaling. The company also deals with all issues related to loading, delivery, customs clearance and unloading of the equipment, start-up, validation/qualification and subsequent maintenance services.
Following the 5 years, X-TECH has taken a significant market share and become one of the three major suppliers of pharmaceutical industrial equipment, working with the industry leaders. At present, X-TECH is an exclusive representative of foreign partners in the Russian Federation. The company cooperates with partners from South Korea, European countries such as Italy, Spain, Switzerland, etc. It’s Russian clients are located in Novosibirsk, Saransk, Belgorod, Yaroslavl, St. Petersburg, Moscow, etc.
One of the key priorities for X-TECH is ensuring the technological progress of Russia.
In a week, on November 16, the ISPE EAEU Annual Conference begins featuring regulators from EAEU member states participating in almost every session of the event. 11 representatives of regulatory bodies and international agencies will participate in the ISPE EAEU Annual Conference which will be held in Moscow on November 16-18. Thus, Dmitry Galkin, Director of the Pharmaceutical and Medical Industry Development Department of the Russian Ministry of Industry and Trade, and Vladislav Shestakov, Director of “SID and GP”, are expected to take part in the session “International Integration of Professional Pharmaceutical Community of Russia and EAEU”.
Dmitry Rozhdestvensky, Head of the Section for Coordination of Work in the Field of Circulation of Medicines and Medical Devices of EEC Technical Regulation and Accreditation Department, will present the review of adaptation and implementation practices of European Union’s GM(D)P regulations to the EAEU legal framework at the Regulatory Table panel discussion. Mkrtych Shakaryan, Head of Good Manufacturing Practices Department in the Scientific Center of Drug and Medical Technology Expertise after Academician Emil Gabrielyan of the Ministry of Health (Armenia), will continue discussing this topic, but in the aspect of application of recommendations of professional pharmaceutical communities and guiding documents in the field of G(M)DP to the training of pharmaceutical inspectors
The representatives of the Russian GMP inspectorate Nataliya Chadova, Head of Pharmaceutical Production Inspection Department the Head of Directorate for Inspection of Drug Manufacturing and Expertise of “SID and GP”, and Madina Sottaeva, Deputy Head of the Directorate for interaction with EAEU of Directorate for Inspection of Drug Manufacturing and Expertise of “SID and GP” will speak at this session in the Q&A format. Yulia Koltovich, Chief Specialist of the Pharmaceutical Inspection Department of the Ministry of Health of the Republic of Belarus, will also take part in the regulators’ discussion regarding the results of inspection for compliance with GMP requirements. Yulia Yuriyevna will also talk about the activities of the Pharmaceutical Inspectorate of the Ministry of Health of the Republic of Belarus in terms of organization of GMP inspections paying attention to the current state of the regulatory environment in this field. Tatyana Nikolko, the Expert Advisor of the Executive Director of the Eurasian Academy for Good Practices, will finalize the Roundtable Discussion with regulatory participation and answer the questions about the joining of the Russian GMP Inspectorate to the Pharmaceutical Inspection Co-Operation Scheme (PIC/S).
Representatives of regulatory agencies will participate in the second day of the ISPE EAEU Annual Conference: Jean Francois Duliere, member of the EMA Work Group for Annex 1 EU GMP, will inform the participants of the event with the last amendments associated with the development of a new revision of Annex 1 to EU GMP; Natalya Burlakina, Lead Specialist of the Department of Drug Manufacturing Inspection of “SID and GP” will present a comparative analysis of the approaches of regulators in different countries to the Pre-use Post Sterilization Integrity Testing (PUPSIT) of sterilizing filters and will tell about potential causes for their testing. Both speakers will speak in the Harmonization of Drug Manufacturing Requirements session. Igor Falkovsky, Technical Director for Good Engineering Practices of the “SID and GP” inspection body, will traditionally take part in the Pharmaceutical Engineering session of the ISPE EAEU Annual Conference. This time he will present the experience of independent expertise of pharmaceutical productions and will tell about the results of non-optimal or poorly thought-out engineering solutions adopted by customer and designer at various stages of the life cycle of a pharmaceutical enterprise.
We remind that the ISPE EAEU Annual Conference will be held in Moscow on November 16-18. The event will also be webcasted. If you have not registered yet, please, hurry up to do that using this link. The general partner of the event is Skopin Pharmaceutical Plant (Ryazan), the main strategic partner is R-Pharm Group, which consolidates 9 high-tech industries and 70 branches in 30 countries. Traditionally, the special partner of the event is the Russian branch of bioMérieux – bioMérieux Rus LLC. The Conference will be held also with the support of X-TECH, supplier of equipment and complex solutions for pharmaceutical enterprises, POLYSAN, AKRIKHIN JSC, and Valenta Pharm pharmaceutical companies, AbbVie biopharmaceutical company. Among the Conference 2021 partners is LegisPharm company, specialized in preparation, filing and maintenance of dossiers for medicines and medical devices. Informational support for the ISPE EAEU Annual Conference is traditionally provided by both Russian media and leading industry publications of EAEU member states, including Pharmaceutical Review of Kazakhstan, Kazakhstan Pharmaceutical Bulletin, and Pharmaceutical Industry. The Association of International Pharmaceutical Manufacturers in the Republic of Kazakhstan is a regular regional partner of the event. The general industry partner is PharmVestnik; strategical informational support is provided by National Pharmaceutical magazine. Traditionally, the conference is supported by Pharmprom.RF, Pharmmedprom, Pharma RF, “Pharma-Technologies and Packing” magazine, GxP news, Regions of Russia, “Moscow Pharmacies” pharmaceutical newspaper, “Drug Development and Registration” R&D magazine, Yellmed, Clean Rooms and Process Media, Remedium Group, Inpharm portal, “Who Is Who in Medicine” specialized magazine, and the Chemical Expert magazine.
On November 16 at the ISPE EAEU Annual Conference as part of the session “Overview of ISPE Guidelines Updates as of 2020-2021”, the authors, representatives of pharmaceutical companies and educational centres presented key provisions and shared their experience in implementing modern ISPE Guides.
The ISPE EAEU Annual Conference continues in Moscow. A session focused on the overview of new ISPE EAEU Guides published in 2020-2021 ended just a couple of minutes ago. When reviewing new products, the conference participants learned how to build a knowledge management process in the pharmaceutical industry, improve the CAPA system and which methods are most efficient in controlling the cleaning validation lifecycle. The session was opened by the report of Associated Director Merck&Co Melanie Adams on practical aspects on implementing into the pharmaceutical industry one of the recent ISPE Good Practice Guides: Knowledge Management in the Pharmaceutical Industry.
For the first time, knowledge management was identified as one of two tools supporting the pharmaceutical quality system development in ICH Q10 2008. The importance of knowledge management was highlighted in ICH Q12 2020. These indicators are included in the Good Practice Guide.
“Establishing an effective KM strategy requires a change from current business practices and ways of working for most organizations, implementing a culture embracing KM is an advantage to all aspects of the pharmaceutical industry,” – one of Guide’s co-authors Melanie Adams believes. “The Guide on Knowledge Management in the Pharmaceutical Industry discusses organizational change management to facilitate colleague engagement and ensure people understand the reasons to focus on KM and successfully adopt more effective ways of working.” The next novelty presented at the ISPE EAEU Annual Conference by Head of the VIALEK International Training Center Alexander Alexandrov , was APQ Guide: Corrective Action & Preventive Action (CAPA) System. “This is the first Guide in a series that includes three more Guides –Management Responsibilities and Management Review, Change Management System and Process Performance and Product Quality Monitoring System, – Alexander Alexandrov informed the audience.
Advancing Pharmaceutical Quality is an improved (breakthrough) approach to ensure pharmaceutical quality, which describes a model for the integrated assessment of the maturity level by PQS elements and development of action program to improve it. The APQ Guide: Corrective Action & Preventive Action (CAPA) System provides guidance and templates for self-assessment of CAPA compliance based on the APQ model, and also introduces CAPA benchmarking practices. This Guide for those who are well versed in CAPA. It allows CAPA specialists to compare their level, the level of their enterprise with others”, – believes Alexandrov. To do this, the Guide has 7 elements:
CAPA Documentation
Problem Identification
Root Cause Identification
CAPA
CAPA Effectiveness
CAPA Metrics
CAPA Governance.
The annual ISPE EAEU Conference is held in Moscow on November 16-17 with the support of the Ministry of Industry and Trade of Russia.
The general partner of the event is Skopin Pharmaceutical Plant (Ryazan), the main strategic partner is R-Pharm Group, which consolidates 9 high-tech industries and 70 branches in 30 countries. Traditionally, the special partner of the event is the Russian branch of bioMérieux – bioMérieux Rus LLC. The Conference will be held also with the support of X-TECH, supplier of equipment and complex solutions for pharmaceutical enterprises, POLYSAN, AKRIKHIN JSC, and Valenta Pharm pharmaceutical companies, AbbVie biopharmaceutical company. Among the Conference 2021 partners is LegisPharm company, specialized in preparation, filing and maintenance of dossiers for medicines and medical devices.
The ISPE EAEU Annual Conference was held in SEZ Technopolis Moscow. The second day of the event began with the session “Harmonized Approach to Manufacturing Pharmaceutical Substances”. The session was opened by the Advisor to the General Director for Quality Assurance of General Partner of the ISPE EAEU Annual Conference – Skopin Pharmaceutical Plant – Evgenia Oleynikova
Evgenia Oleynikova, Advisor to the General Director for Quality Assurance of SCOPINPHARM, made a report on the practical implementation of GDP requirements in the context of GMP rules. As we remember, the rules of Good Manufacturing Practice for medicines are cited in EEC Council’s Resolution No. 77, while the rules of Good Distribution Practice are cited in EEC Council’s Resolution No. 80. The EAEU GMP rules contain clauses that apply both to the distribution of medicines and, in some cases, to the distribution companies themselves. For example, as per Chapter 1 (“Pharmaceutical Quality System), EAEU GMPs, “The distribution of the products minimises any risk to their quality and takes account of Good Distribution Practice,” and according to Chapter 5 (“Production”), “For the approval and maintenance of suppliers of active substances and excipients, it is required to carry out audits of manufacturers and distributors of active substances. The holder of the manufacturing authorisation shall verify such compliance either by himself or through an entity acting on his behalf under a contract” – the representative of SCOPINPHARM emphasized. Referring to the second quote, in particular, when choosing a API supplier (distributor), Evgenia Oleynikova recommends taking into account the acceptance criteria, conduct an off-site assessment by questionnaires prior to concluding a contract, request samples for laboratory and production tests, conduct physical or desktop audits, analyse risks, and perform statistical analysis of product quality to identify trends and prepare a dossier on a supplier.
Speaking about the requirements for distributors of pharmaceutical substances, the Advisor to the General Director for Quality Assurance of SCOPINPHARM drew the attention of the participants of the “Harmonized Approach to Manufacturing Pharmaceutical Substances” session to the fact that Part II of the EAEU GMP, which regulates the requirements for API manufacture, has section 17, which refers to any party other than the original manufacturer who may trade and/or take possession, repack, relabel, manipulate, distribute or store an API or intermediate. Such distributors should
At the ISPE EAEU Annual Conference, Head of Administration for Pharmaceutical Products Inspection and Evaluation of FSI “SID & GP”, Advisor to the Executive Director of the Eurasian Academy of Good Practices Tatyana Nikolko informed about the state of affairs on the issue of joining Russian competent authorities in the field of medicines to the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), the experience of the Russian GMP inspectorate on the way of accession and the current “Applicant” status (Applicant for accession to the PIC/S).
The procedure for Russia’s accession to PIC/S has been regularly discussed since 2017. It was from this year that the modern history of the issue began, which roots go back to 2010, when a Memorandum of Understanding was signed between Roszdravnadzor and PIC/S.
The process of accession of Russian regulators/GMP inspectorate to the Pharmaceutical Inspection Co-Operation Scheme after the work group formation in February 2017 passed the 1st stage “PIC/S Pre-Accession” and part of the 2nd stage. At the first stage, in August 2017, the Ministry of Industry and Trade of Russia and its subordinate “SID & GP” applied for pre-accession to PIC/S. After receiving recommendations from the PIC/S on the need to expand the list of applicants by other competent authorities of the Russian Federation, such as Roszdravnadzor, the Ministry of Health of Russia with state quality control laboratories, also responsible for some of the regulatory issues in the field of medicines, the application was finalized, the list of applicants was expanded and filed for the second time in August 2019. In November of the same year, the PIC/S Committee made a positive decision for the “Pre-accession” application; Russian regulators received an official letter from PIC/S about closure of the Pre-Accession stage in April 2020.
At the second stage, specialized regulators prepared documents for an application for accession, initiated changes in legislation related to medicine regulation and inspection, updated and improved quality systems in the competent authorities. To apply for accession, a roadmap and action plan were developed. The application was submitted on December 24, 2020, assessed by the PIC/S Secretariat for completeness, and from February 2021 the preliminary procedure for assessing the accession documents began. According to the PIC/S Accession Guidelines, the assessment of compliance with the PIC/S Regulatory Compliance Program is limited to 6 years. During this period, it is possible, in particular, to conduct a physical assessment audit of applicants by PIC/S and to eliminate the comments identified during the audit and the general assessment of documents,” Tatyana Nikolko emphasized.
In her speech Tatyana Nikolko said that membership in PIC/S is a kind of international recognition of the adequacy of the GMP inspection system of the Inspectorate of a particular country, which ensures a higher rating and index of credibility to such inspectorate/competent authority on the part of regulators and manufacturers from other countries “If the rating and c index of credibility increases in connection with membership in the PIC/S, this helps to remove a number of barriers and facilitates conclusion of bilateral or multilateral international agreements, which, as practice shows, are the most efficient form of international cooperation, including in the area of drug commerce, in terms of import control optimization, as well as strengthening and developing the export potential of the national pharmaceutical industry. Accession to PIC/S can be regarded as a basic step for entering into such agreements”, – believes the Speaker – “However, membership in the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) does not provide automatic mutual recognition of inspection results, but increases the mutual trust of involved regulators. The international drug commerce environment in today’s context requires further efforts to converge both organizational approaches to surveys of enterprises and methodology of inspections for compliance with the GMP rules in different countries.
What are the Lessons Learned and what shall be improved?
Tatyana Nikolko believes that the assessment of the received comments and identified inconsistencies in the process of document preparation for applying for PIC/S accession, striving for compliance with the PIC/S Regulatory Compliance Program (checklist indicators and questionnaire), lessons and achievements of recent developments in the world commit us to focus on strategic areas such as
The ISPE EAEU Annual Conference was held in Moscow on November 16-17.
The general partner of the event is Skopin Pharmaceutical Plant, the main strategic partner is R-Pharm Group, which consolidates 9 high-tech industries and 70 branches in 30 countries. Traditionally, the special partner of the event is the Russian branch of bioMérieux – bioMérieux Rus LLC. The Conference will be held also with the support of X-TECH, supplier of equipment and complex solutions for pharmaceutical enterprises, POLYSAN, AKRIKHIN JSC, and Valenta Pharm pharmaceutical companies, AbbVie biopharmaceutical company. Among the Conference 2021 partners is LegisPharm company, specialized in preparation, filing and maintenance of dossiers for medicines and medical devices.
Informational support for the ISPE EAEU Annual Conference is traditionally provided by both Russian media and leading industry publications of EAEU member states, including Pharmaceutical Review of Kazakhstan, Kazakhstan Pharmaceutical Bulletin, and Pharmaceutical Industry. The Association of International Pharmaceutical Manufacturers in the Republic of Kazakhstan is a regular regional partner of the event. The general industry partner is PharmVestnik; strategical informational support is provided by National Pharmaceutical magazine. Traditionally, the conference is supported by Pharmprom.RF, Pharmmedprom, Pharma RF, “Pharma-Technologies and Packing” magazine, GxP news, Regions of Russia, “Moscow Pharmacies” pharmaceutical newspaper, “Drug Development and Registration” R&D magazine, Yellmed, Clean Rooms and Process Media, Remedium Group, Inpharm portal, “Who Is Who in Medicine” specialized magazine, and the Chemical Expert magazine.
Director of the Project Management Department SCOPINPHARM Eduard Murakhovsky shared the main lessons of implementing cutting edge tools from the international and Russian digitalization experience.
The business program of the ISPE EAEU Annual Conference ended yesterday in Moscow. The event was closed by the “Digitalization of the Pharmaceutical Industry” session, within which a comprehensive view was given to the trends of digital transformation and implementation of artificial intelligence technologies. Thus, Director of SCOPINPHARM’s Project Management Office Eduard Murakhovskiy drew attention of conference participants to the fact that in the course of information system implementation it is always necessary to perform so-called “negative scenario” testing, which shall check these systems for durability and stable functioning in a real situation, efficient response to the challenges of exogenous uncertainties and ability of uninterrupted operation under conditions other than planned by the scenario.
“If a system is designed as if it operates in an ideal digital landscape with 100% correct data and perfectly behaved participants, its collapse is just a matter of time,” the SCOPINPHARM’s representative says.
How to avoid problems?
The speaker demonstrated a typical system development cycle based on the waterfall model, which begins with the analysis of requirements, then come the design, performance stages and testing, and only after that go support and implementation. “It is at the testing stage when it becomes possible to get rid of all the flaws that could discredit the entire idea of digital transformation,” Murakhovskiy notes – “But, of course, testing is only part of a more general quality control (QC) system, which includes analysis of test results, their processing and drawing up of opinions about deviations. The quality control system itself is part of a more general concept – a quality assurance system (QA). In this case, it is not just about the development of a single software or an individual digital platform, but about the methodology and organization of the development process, including verification of requirements and characteristics, risk assessment, preparation of documentation, testing and analysis of its results. This enables a critical look at the process, allows for evaluation and identification of weak points, performance of verification and validation procedures.”
Verification will show us how the system meets the original developer’s requirements, and validation will determine how it meets users’ expectations and needs. We must strive to ensure that the both results coincide: “So that the developer wrote in the Terms of Reference exactly what the user needs, despite the intrinsic difficulties in formalizing the expectations of system’s users,” Murakhovskiy emphasized.
Speaking about artificial intelligence, the Director of SCOPINFARM’s Project Management Office noted that according to the results of a survey conducted in November 2021 by the MIT Sloan Management Review and BCG, 62% of executives positively assess the impact of artificial intelligence on business processes. At the same time, according to FICO’s and Corinium’s survey, 65% of executives in leading companies actively using artificial intelligence systems cannot explain how their artificial intelligence systems make decisions that are important for the company and stakeholders. According to Eduard Murakhovskiy, such gap in the importance and understanding of artificial intelligence is one of the key obstacles to putting this technology into practice.
Isn’t it impossible to do without human intervention?
First of all, any company and its top management should remember that the concept of “artificial intelligence (AI)” is used in two main meanings: applied AI and general AI. The latter, according to Eduard Murakhovskiy, is a dream – “This is something that exists only in the imagination of science fiction writers so far, possesses all features of human intelligence and is able to solve any problems on-the-go.” Naive optimists are confident that artificial intelligence will save us all, it will figure everything out by its own, decide everything, do everything, including in manufacture.
However, what really exists is applied artificial intelligence, i.e. advanced automation systems that are designed to solve specific problems, they work very well, but the range of their tasks is limited.
Applied AI is not so simple as well, but is solvable. The main thing is to avoid traps on the way to its efficient use. Murakhovskiy distinguishes the following traps:
“The artificial intelligence we have today lacks a deep understanding. AI is a tool that is good at finding correlations, but it cannot reveal cause-and-effect relationships. It looses its efficiency even at a slight change in conditions. This means that we need to remember that only a person responsible for setting tasks for artificial intelligence has deep understanding,” Eduard Murakhovskiy summed up.
At the Annual Conference of ISPE Eurasian Affiliate, held in Moscow on November 16-18, 2021, experts from the pharmaceutical community – representatives of regulatory bodies, engineering and manufacturing companies from different countries talk about key pharmacy trends, share the latest information on new laws and analyse the experience of independent expertise of pharmaceutical industries. Thus, on November 17, Igor Falkovsky, Head of Engineering and Design at FSI SID & GP, elected to the Board of Directors of the ISPE EAEU Affiliate, presented an analysis of non-conformities with GMP at existing production, which most likely resulted from errors at the design stage.
The great majority of non-conformities found at existing production in the course of self-inspections, external inspections and audits is due to the following three reasons:
While human error or loss of control over operating environment are commonly stated as the direct source of a non-conformity, the root cause study often speaks for design errors.
Nonconformities, which root cause is most likely associated with suboptimal and/or ill thought-out technical solutions at the design stage – the “design-related” GMP non-conformities, as a rule, refer to the following sections of GMP requirements:
As Igor Falkovsky showed in his report, “design-related” non-conformities are associated with planning and process solutions of production and storage areas, including sampling rooms, quality control areas as well as their utilities.
“Design-related” non-conformities result in the need to use the premises for personnel pass-through, in excessive workload on production that does not correspond to the production program scope, in violating the clean room classes, thereby increasing the risk of contamination and mix-up to an unacceptable level.
The report provides examples of ill-conceived planning and process solutions that led to microbial contamination of injection products, batch recalls from the market, suspension of production, and, as a result, to economic losses.
“As a rule, people try to “correct” unsuccessful planning decisions by organizational measures, but there is a high probability that this approach will not work,” Falkovsky said.
When summing up, Igor Falkovsky noted that the high quality of design solutions, including assessment of potential vulnerabilities of processes and a holistic comprehension of operational factors interaction, should be formed in close collaboration between the Designer and interested representatives of the Customer. Optimal and reliable design solutions that meet Regulator’s requirements can be developed only if all design process participants are aware of their responsibility.
Session “Pharmaceutical Engineering and Design” was held on November 17 as part of the ISPE EAEU Annual Conference with the support of POLYSAN.
The ISPE EAEU Annual Conference addressed the specifics of conducting rapid analyses for sterility and the features of manufacturing and laboratory engineering for biomedical cell product manufacture.
The ISPE EAEU Annual Conference has a number of distinctive features that make it stand out in a series of industry events. This is a presentation of the most relevant trends in legislation aimed at regulating medicines manufacture and commerce in various countries already at the stage of preparing amendments to regulatory documents. The second distinctive feature is associated with a high level of practical aspects, through the prism of which the most complicated issues of regulatory acts are being analysed.
During the “Harmonized Approach to Manufacturing Pharmaceutical Substances” session, Director of Healthcare Scientific Affairs at bioMérieux, Arnaud Pari, speaking about rapid analyses for sterility, noted that in terms of BMCPs, the European Pharmacopoeia contains an article on the use of automated microbiological control of cell preparations. A number of chapters of the American Pharmacopoeia dedicated to sterility are being amended. In particular, the work on articles about rapid microbiological methods based on the detection of microorganism respiratory products or ATP bioluminescence technology for manufacture of pharmaceutical products with a short shelf life is in progress. Articles appear about rapid analyses for sterility of products with a short shelf life based on a risk-based approach. Sterility analyses are also present in the pharmacopoeias of Russia and the EAEU, but the point at issue is traditional manual methods of analysis. “Alternative methods of sterility analyses, not yet been adopted, are being developed all over the world, which provides for existence of a number of recommendations for them,” Arno Pari said, – “At the same time, in the part of validation of alternative sterility analyses based on GMP principles, the European Pharmacopoeia states that the full validation of rapid analysis shall show at least equivalence to the pharmacopoeia method. However we shall not forget that the “pharmacopoeia” status for rapid methods will limit validation only to defining method’s applicability (suitability) to the product.” To date, there are several guidelines and validation documents for rapid microbiological methods. They are: Monograph No. 5.6.1 of the European Pharmacopoeia on Alternative Methods for Control of Microbiological Quality; examples of validation protocols for such methods in the EDQM Guide; Monograph No. 1223 of the US Pharmacopoeia, dedicated to validation of alternative microbiological methods; Technical Report PDA no.33 on Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods.
Today bioMérieux offers 2 rapid sterility test technologies:
an automated method based on CO2 detection, for which bioMérieux has developed a system called BACT/ALERT 3Dâ DUAL-T,
direct detection method based on solid phase cytometry using the
SCAN RDIâ system.
“BioMérieux’s rapid sterility testing tools are currently used by 75% of sites producing sterile and non-sterile category 503 b OTC mixtures for US companies under contracts, and the US FDA uses SCAN RDI as a diagnostic tool when it receives reports of suspected product contamination,” Arnaud Pari said.
Alexey Lyundup, Executive Director of the Association of Biomedical Cell Products Manufacturers, continued talking about BMCPs. The speaker noted that currently there are about 40 registered cell preparations in the world, and CAR-Ts (T-cell therapy with chimeric antigen receptor) are the top-selling cell preparations – they account for more than 1 billion US dollars a year. The market leaders are of course companies from the USA, Japan, Great Britain, China, and South Korea. “In total, the market has more than 700 companies which IP is represented by over 30,000 patents and over 700 clinical trials,” Alexey Lyundup emphasized.
Taking into account the rapid growth of the global BMCP market (on average by 22% per annum), pharmaceutical companies are interested in setting up the production of such products. However, companies shall take into account some peculiarities of manufacturing and laboratory engineering for cell preparations:
“Today in Russia there is only one licensed site for BMCP manufacture,” the speaker emphasized.
The “Harmonized Approach to Manufacturing Pharmaceutical Substances” session was held on November 17 within the framework of the ISPE EAEU Annual Conference with the support of X-TECH, which specializes in complex solutions in the design, supply and commissioning of equipment and production lines.
At the ISPE EAEU Annual Conference, representatives of design companies and pharmaceutical manufacturers told where the design and engineering vector is shifting nowadays.
Many people believe that ISPE is an association dealing only with engineering issues, but today the association covers the entire scope of issues related to the implementation of the GM(D)P-practices. However, the agenda of all ISPE business events traditionally includes an engineering session, where designers, representatives of specialized associations and pharmaceutical manufacturers highlight the topical issues in this sphere. This year the “Pharmaceutical Engineering and Design” session was opened by the report of Director of G.М. Project-Rus Alexey Topnikov about biopharmaceutical manufacture engineering features, which, as the participants of the ISPE EAEU Annual Conference learned from the “Harmonized Approach to Manufacturing Pharmaceutical Substances” session, are one of the key trends in future development of the pharmaceutical industry. That is why the issues of proper design of such facilities come to the fore. A very important step of creating a biopharmaceutical manufacturing facility — just like any other pharmaceutical manufacturing, — is the first design stage, development of a concept, concept design, – Alexey Topnikov noted.
Concept development begins with study and analysis of the final product properties and analysis of risks associated with such properties. In terms of the final product properties and product manufacturing technology, the most significant are the risks of contamination from the external environment, cross-contamination during parallel manufacture of several products, cross-contamination during the sequential batch production using biomaterials from different donors. “As a rule, biological agent used or cell manufacturing are classified as pathogen risk groups 3-4, which also creates certain risks for personnel and environment that have to be reduced to an acceptable level through design solutions” – Alexey Topnikov noted. Since a cell preparation, on the one hand, is injectable (i.e., must be sterile), and on the other hand, contains living cells (i.e., is non-sterile “by default”), it shall be manufactured as a sterile product made under aseptic conditions. Here, one should take into account that the final product is not subjected to sterile filtration. We must apply methods that protect critical operations and preserve the critical quality parameters of the product, so as not to expose it to contamination or to any other negative impact,” the speaker pointed out to the conference participants.
In terms of biotech products, the ISPE Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 2nd Edition is predominantly based on the use of closed systems. In particular, according to the fourth chapter thereof, the modern approach to creation of biopharmaceutical manufacturing shifts the focus from standard engineering methods of protecting critical operations towards closed systems. “We must avoid open operations as much as possible and protect them using disposable systems or isolator technologies,” Alexey Topnikov explained.
Speaking about cooperation with X-TECH and Sartorius in the creation of a COVID-19 vaccine production facility, Topnikov noted: “Now we are at the stage of optimizing chromatographic purification, i.e. use of pre-filled, solid-state disposable columns that can be easily replaced after use, which eliminates cross-contamination from process to process.”
Isolator technologies are the most reliable way to protect critical operations for different types of biopharmaceutical production facilities. They help to minimize the related risks in parallel manufacture of several batches/types of products.
The paradigm of the approach to generating planning decisions when using closed systems is changing. This applies not only to sterile products. The G.M. Project-Rus has a successful experience with DEC, which offers PTS valve systems, closed transfer of materials or semi-finished products. “We made several solutions where instead of separate rooms or boxes accommodating the equipment, we have a large hall with almost all main equipment units. This is quite consistent with the concept of the ISPE Biotechnology Guide, which proposes the use of all cell cultivation stages (both pre-viral and viral) in a single room, using closed systems,” Alexey Topnikov surprised the audience.
Dmitry Polstyanov, X-TECH CEO, continued talking about closed systems and made a report on the automation of solid dosage forms manufacture as one of the ways to improve product quality and reduce costs. Thus, the company has implemented a project for POLYSAN’s facility in Belgorod with the use of closed technologies: “We applied a closed technology in a clean stage for API manufacture and were able to partially avoid the use of clean rooms within the process line. In other words, the final process of product final drying, averaging, grinding and packaging was brought outside the clean rooms by looping the process using the “closed loop” technology,”– Dmitry Polstyanov told about the unique project. The speaker also noted that in addition to the demand for closed systems, manufacturing flexibility and multitasking of operations are in trend now. One of the methods of manufacturing automation and flexibility is a combination of processes, uniting several process stages into one without breaking the process chain, using PAT technologies. “This is the first step towards continuous manufacture and quality control, elimination of the human factor and risks of product contamination,” Polstyanov believes.
Andreas Polz, Project Manager for Pharmaceutical Plants Construction at ZETA GmbH, continued to talk about contemporary design and construction concepts in pharmacy. The speaker presented a number of examples when the company implemented projects in the shortest possible time (2 years: from project start to facility commissioning) by paralleling a number of processes.
POLYSAN Technical Director Alexander Stavash presented the standpoint and view of manufacturers of medicines (namely active pharmaceutical ingredients (API)) concerning the design and engineering process. Noting that the company’s (Polysintez) site in Belgorod is currently under revamping, the speaker dwelled on the prospects and challenges of API continuous manufacture by chemical synthesis. The following prospects were noted:
However not all processes can be made continuous. For example, dissolution of solids in a stream, terminal sterilization, etc. Among the problems of continuous manufacture, Alexander Stavash distinguished poor availability of the necessary equipment that ensures accurate continuous dosing of reagents into the stream, as well as limited availability of special instrumentation, methods of analysis and control of continuous processes. And of course, the risks to the final product must not be forgotten. In addition, there is also a factor of economic feasibility: a change in process entails changes in infrastructure. “If the market requires a rapid increase in manufacture of specific products, it is sometimes more profitable to build a new facility, to start a new line. It’s scarcely feasible to switch to a continuous process just for one product,” Alexander Stavash states.
Session “Pharmaceutical Engineering and Design” was held on November 17 as part of the ISPE EAEU Annual Conference with the support of POLYSAN.
On November 16-18, EAEU ISPE Annual Conference was held in Moscow. The event was attended by representatives of 63 companies. 37 speakers delivered reports at 6 topic sessions, and on the third day of the Conference, 30 participants visited 2 production sites: Berlin-Chemie / Menarini, and Novo Nordisk.
Among all conferences that organizers are trying to fit in the busy schedule of pharmaceutical companies amidst easing quarantine measures and in COVID free conditions, Annual ISPE EAEU Conference is of particular interest. The industry’s close attention results from high-quality reports, the opportunity not only to exchange experiences with colleagues and top experts, but also to get acquainted with new vocabulary. In particular, the Conference participants traditionally praise speeches of quality experts: Tatiana Vyazmina ( R-Pharm Group) and Faiza Yagudina (AKRIKHIN). Some delegates emphasize one of the most relevant topics — contract manufacturing. Engineering professionals always focus on targeted issues (e.g. QbD in design and construction concepts). Practice-oriented approach is also named among the advantages and reasons to attend the event. Participants got interested in Dmitry Polstyanov’s (X-TECH) report on the introduction of bic spectrometer to determine homogeneity of mixing components in a mixer for solids. And of course, the icing on the cake of positive emotions of participants was the chance for 30 lucky ones to visit the operating production sites of Kaluga Pharmaceutical Cluster. This opportunity is especially valuable at a time when pharmaceutical factories rarely allow visitors to their facilities.
«For the first time, ISPE Eurasian branch management, despite the tough covid restrictions, was able to organize offline visits to some of the best pharmaceutical companies in Russia,» said Vladimir Orlov, Director of the ISPE EAEU. «After negotiating with the production facilities and ensuring compliance with all quarantine measures (including vaccination certificates and recently made PCR tests), randomizer chose 2 groups of representatives of Avexima JSC, Biohimik JSC, Veropharm JSC, GEROPHARM LLC, Grotex LLC, Medsintez Plant LLC, Nanolek LLC, Advanced Pharma LLC, Moscow Endocrine Plant FSUE, and Stavropol Biofactory FSE. On November 18, the groups went to the Novo Nordisk plant specializing in the production of modern insulins in the form of injection, in particular in the form of pre-filled syringe pens with cartridges, and the Berlin-Chemie / Menarini plant, whose staff has been cooperating with ISPE for years.» This year, Elena Kataeva, Quality Director at Berlin-Chemie / Menarini, participated in the ISPE EAEU Annual Conference remotely and highly appreciated its content and relevance.
As part of an excursion tour to Novo Nordisk conducted by Andrey Chueshov, Head of the Production Environment Monitoring Department, representatives of pharmaceutical companies saw the equipment and the main premises of the production area, including the area for solution preparation, filling, and production of aseptic formulations. In addition to the main production areas, guests examined the secondary packaging area and the assembly line for syringe pens — combined product, both a drug and a medical device. “The novelty of this excursion was to demonstrate the company’s internal laundry zone. This practice is unique for Russia. The plant has built and operates its own room for washing workwear of all cleanliness classes. It is being washed, sanitized, sterilized and prepared for use in clean zones,” Vladimir Orlov noted.
In addition, the excursion tour to the Novo Nordisk plant showed rooms for engineering systems, in particular, for water treatment systems, which include plant for injection water treatment by methods of distillation or pure steam. Even before the excursion, after the introductory briefing, the guests had the opportunity to try on the role of an operator, an assembler of the NovoRapidâ FlexPenâ insulin syringe pen. Everyone tried to assemble and tested a pen with variable volume.
Visit to the Berlin-Chemie / Menarini plant left no less impressions: “The trip to the plant brought forth a lot of positive emotions — it is always interesting to see an enterprise from the inside, compare it with our own experience and learn the best,” the excursionists admitted. Labelling process keeps on arousing particular interest in visitors to pharmaceutical companies.
Their acquaintance with the Berlin-Chemie / Menarini plant in Kaluga began with the enterprise presentation. Consultant (ex general director) Irina Braginskaya and General Director of the plant Viktor Moiseev shared their experience and approaches to the design of premises, lines, layouts of production blocks used when building an enterprise in Kaluga Pharmaceutical Cluster. Further, guests visited quality control laboratory, then, thanks to the modern design system of production facilities and glass walls, they saw the full production cycle: from raw materials and packaging preparation, to putting drugs in boxes. Visitors were especially interested in the system for sample archiving; they noted the special ergonomics and security system. Just like the Novo Nordisk enterprise, Berlin-Chemie / Menarini has its own laundry room whose processes were explained to the guests. Chief Power Engineer demonstrated engineering systems to the participants of the ISPE EAEU Conference paying particular attention to water treatment systems, including water and pure steam generation system. Visitors paid special attention to the internal regulations for production maintenance.
The excursion was also attended by journalists who ventured to take their eyes off monitors and attend the Annual ISPE EAEU Conference in person. In between sessions of the business program, they were shown a clean area, taught how to dress and undress in it, and saw a module of biotech production used in Sputnik V release. Media representatives used a chance to see all this at the R-Pharm training centre organized in the SEZ Technopolis Moscow on the basis of the Moscow State Educational Complex.
“Taking into account the feedback of the conference participants after excursions, this practice will become regular for the Annual ISPE EAEU Conference”, Vladimir Orlov said. The next conference will take place in autumn 2022.
During the ISPE EAEU Annual Conference Tatiana Vyazmina, Quality Director of Russian Group of Companies R-Pharm, spoke about complications a company may face when transferring drug production from one site to another, and shared her experience of how to avoid such complications.
Joining the ISPE EAEU means access to current guides referred to by inspectorates and regulatory agencies around the world. Adherence to them allows us to guarantee the highest quality of future medicines already at the stage of design and production setting. Through our participation in the association, we are able to exchange views with leading experts in the field of good manufacturing. All this together gives us the opportunity to minimize the major risks associated with various aspects of GMP. R-Pharm Group is a member of many specialized pharmaceutical associations, such as AIPM, ARPP, Inpharma, etc.
Over the twenty years of its existence, R-Pharm Group has achieved great success – we have become the largest supplier of integrated healthcare solutions in the Russian market. Over the years, the company has successfully transformed from a pharmaceutical distributor into a full-cycle manufacturer and developer of innovative methods for the prevention and treatment of socially significant diseases. The competence gained over two decades and a team of high-qualified professionals allow us to withstand the most difficult challenges. Since the start of pandemic, R-Pharm Group has been implementing a program of measures aimed at combating the Coronavirus infection. In the shortest possible time, we provided Russian citizens with access to contemporary medicines, vaccines and diagnostic systems. Speaking about those projects in which my team was actively engaged, I’d like to mention, first of all, the launch of some Group’s manufacturing sites. Thus, at our Rostov plant “Pharmoslavl” we set up production of pharmaceutical substances of chemical synthesis, in Azerbaijan the first country’s complex was built, which included production, logistics and laboratory units. The most important thing for us was opening of a new Sputnik Technopolis plant in Moscow. It launched the production of vaccines intended to protect population from the Coronavirus infection. There are some other large-scale projects under development, including a medicine manufacture facility in Alabushevo, the first cycle launch is scheduled for 2022
The complications we face in the course of drug manufacturing transfer between different site of the same company, are as follows:
– incomplete preparedness/unpreparedness of the site personnel to manufacture a new form or a new type of drug, personnel training takes time;
– technology transfer and scaling are often associated with the issues concerning process parameters and quality indicators of the drug established in the course of development. This requires technology changes and adaptation and sometimes changes in test methods. This is obviously a resource-consuming process;
– problems also arise with a formal approach when transferring technology – when only documentation is provided, which leads to a lack of knowledge about the process and methods. This is a situation when R-Pharm JSC owns marketing authorizations for drugs developed abroad, and the drug is produced by a third party. In this case, R-Pharm JSC is the transferring party, which in fact, does not possess in-depth knowledge of technology or methods. And it becomes a hostage of circumstance;
– differences in the requirements of regulatory legal acts, laws and pharmacopoeias of various countries, for example, in the Russian Federation and the European Union.
Algorithms for Solving Problems during Technology Transfer
A competent responsible transfer team of the receiving and transferring parties, interest and focus on results will help to solve problems associated with the transfer.
On November 9, a round table session dedicated to new trends of pharmaceutical industry digitalization will take place within the frame of Annual ISPE EAEU Conference.
On November 9-10, an Annual ISPE EAEU Conference will be held in St. Petersburg, supported by the Ministry of Industry and Trade of Russia. As displayed by the last year experience and confirmed by the current practice, digitalization in pharmaceutics is in the highest demand. Thus, for three hours, leading experts and managers of pharmaceutical companies, representatives of sectoral associations and regulators will be discussing the many aspects of data integrity through the whole life cycle of a drug, sharing digitalization cases in real-life plants, and looking for digital tools of pharmaceutical development acceleration.
As it is customary already, foreign ISPE branch will present new developments in Pharma 4.0 and respective Guidelines released by the Association. Eurasian branch will deliver the results of a half-year long study of digitalization and its maturity in the companies of EAEU countries. “By integrating the experience of our colleagues from other regions, we strive to find answers to totally practical issues of Pharma 4.0 model integration into production in EAEU: factors influencing computerization degree of GхP-critical processes, or the reasons why the plants still face resistance to digitalization while its importance and benefits are widely recognized by all participants of a production process,” General Director Deputy of ISPE EAEU and long-time moderator of digitalization sessions at the Annual ISPE EAEU Conference, Oksana Pryanichnikova, tells. “The results obtained form a good basis for development of solutions for transformation and customization of the most successful practices, business models and operation procedures during the topical session and in other environments.”
A polling can be taken till November 5. The results of digitalization study will be presented at the Annual ISPE EAEU Conference. To register at the Conference, visit the official website conference.ispe.ru.
In 2022, IT partner of Digitalization in Pharmaceutical Industry session is Akelon IT Company, providing solutions to broadcast key moments of the Annual ISPE EAEU Conference at a Telegram channel.
Time and venue: November 9-10, Courtyard St. Petersburg Center hotel (Griboyedov Canal Embankment 166).
Contacts for questions concerning participation:
S-GROUP Corporate Communications
+7 (495) 120-53-33
conference@sgr.com.ru
On 10 November, the Eurasia Affiliate of the International Society for Pharmaceutical Engineering in cooperation with IT company Akelon will present the results of the poll conducted with support of the media platform GxP News regarding an ideal role model of a pharma professional at the venue of the ISPE EAEU Annual Conference.
During the entire summer of 2022, the EAEU pharma community had a chance to nominate their friends, colleagues, and partners as experts to look up to in work, those admired in life, etc. A total of 40 experts holding different positions were included into the “ideal” and “star” categories: from common pharmaceutical developers to the top managers of large pharma companies whose products are known not only within the EAEU and CIS countries but on other continents as well.
“The international pharma community and, especially, the ISPE members, are aware of the global movement „Women in Pharma“ established to support female experts of the industry. We have decided to further develop this idea into a project „Pharma in Person“ by voting to decide who the industry experts deem to be professionals and role models, by choosing a creative format to present the results of this project which, as well, will be presented in the ISPE global information environment.
Our organisation doesn’t focus on professional issues alone, since, apart from technology, the driving force of the industry and country development includes people, their ideas, and energy. So, we expect our activities in the Eurasia Affiliate of ISPE represented by such emotional and memorable projects to unite soulmates and strengthen the internal links within the pharmaceutical industry,” commented Oksana Pryanichnikova, Deputy Director of ISPE EAEU. Some experts have recorded video addresses that mainly disclose their creed and real-life stories. For example, the participants of the “Pharma in Person” project shared their stories of unusual, fascinating ideas that had occurred to them or their colleagues, told us who they look up to, etc. The final video will be demonstrated at the ISPE EAEU Annual Conference, while individual stories will be published on the Telegram channel IT GxP.
“Any work and success thereof mostly depend on people. The pharmaceutical industry is an orbit of professionals who have undertaken a super task — to assure and maintain health and to bear responsibility for the lives of people around. That is why we can see here such interesting personalities behind whose visible professional success equally interesting life stories are concealed,” initiators of the “Pharma in Person” project commented confidently.
Register for the ISPE EAEU Annual Conference, meet interesting experts, learn new facts about them, and join the “Pharma in Person” project. The project is supported by IT company Akelon, partner of the session titled “Digitalisation in Pharma”, and media platform GxP News acting as the General Information Partner of the conference.
Registration Partner of ISPE EAEU Conference-2022 is web portal proGMP.ru. Special Partner — PQE. Special Partner of the expert round table titled “Modern Approaches to the Monitoring of Production Environment. Methods, Equipment, and Best Practices” — BioMERIEUX Rus, LLC.
Please submit your queries regarding sponsorship and participation to the technical organiser, Corporate communications S-GROUP:
+7 (495) 120-53-33
conference@sgr.com.ru
Time and venue: 9-10 November, Courtyard by Marriott St. Petersburg Centre Hotel (166 Griboyedov Canal Embankment).
