THE INTERNAL AUDITORS OF PHARMACEUTICAL QUALITY SYSTEMS COMPETENCE IMPROVING

The importance of internal audits for the pharmaceutical company, which is indicated in the guidelines for good practices in pharmacy (in particular, GMP, GDP). The issue of selection, training, grading, certification and continuous improvement of the auditor’s competence at pharmaceutical companies are relevant and important both for domestic ones, and for foreign enterprises. The aim of the study was to determine the competence of the pharmacy quality system internal auditors’ and the areas of its development. Materials and methods. The object of the study was the competence of internal auditors of pharmaceutical quality systems. Empirical and theoretical research methods were used, in particular the method of comparative analysis of scientific literature in the field of research, the method of structural and logical modeling. The information basis was the provisions of regulations and materials published in the open professional scientific literature. Results. The competence of quality management system auditors in general and pharmaceutical quality system in particular consists of personal qualities, professional knowledge and skills. The ISO 19011 standard highlights the importance of evaluating and continuous development of auditors’ competence. Such an assessment should take into account the needs of the audit program and its objectives. Areas of development of auditors' competence should be determined by the specifics of industry activities. This provision of the standard should be considered relevant for pharmaceutical companies. Conclusions. We studied the requirements for the competence of QMS internal auditors of international and industry standards. A review of the regulatory framework showed a lack of information on the chosen area of the research. Defined requirements for the competence of the PQM audits staff assists the selection of specialists to the audit team so that the overall competence of the audit team is sufficient to achieve the objectives of the audit

FORMATION OF THE QUALITY MANAGEMENT SYSTEMS AT STATE LABORATORIES FOR A MEDICINES CONTROL

The article reviews the regulatory framework in the field of regulating the activities of laboratories for quality control of medicines at the world and national levels. Taking into account the harmonization of the new version of ISO / IEC 17025 "General competence for testing and calibration laboratories" and ISO 9001: 2015 "Quality management systems. Requirements", the necessity of wide implementation of the process approach and implementation of risk-oriented thinking in the activities of laboratories has been substantiated. The general approaches to implementation of quality management systems in the activity of testing pharmaceutical laboratories are offered. In particular, a typical list of processes of the quality management system (QMS) for the laboratory for quality control of medicines has been developed, and the division of such processes into three groups is proposed: management processes, resource management processes, analytical testing processes. It is substantiated that these groups of processes should be described in the Quality Manual with a mandatory graphic representation of the structure of the process model of the QMS and the description of the conditions for the interaction of processes. The use of the PDCA cycle within each of the processes has been proven to promote systematic measurement, analysis of activities and the development of effective corrective and preventive actions. The formation of effective QMS in state and private laboratories for quality control of medicines will help to reduce the number and significance of inconsistencies and errors in analytical work and processes, to provide proper guarantees for obtaining reliable results, to increase the awareness of staff in quality management methods and continuous improvement of activities

ANALYSIS OF THE TECHNICAL REGULATION STATE OF COSMETIC PRODUCTS TURNOVER IN UKRAINE

The object of research is the state regulation of the turnover of cosmetic products and some aspects of their implementation in Ukraine. Investigated problem. The issue of import substitution of Ukrainian cosmetic products and the increase in their production and sales in the Ukrainian and foreign markets is an urgent reason for the dynamic development of the cosmetic industry and the diversification of its traditional forms and directions of application. The solution to these problems mainly depends on the level of technical regulation by the state and requires proper legislative support in accordance with the requirements of international standards and EU directives. The main scientific results. The foreign experience of regulatory support and state regulation of the turnover of cosmetic products (CP) is summarized. The problems of technical regulation of cosmetic and medicinal cosmetics in Ukraine are identified. An addition to the draft national technical regulation for cosmetic products is proposed and recommendations for its rational use are given. The prospects of introducing quality management systems at enterprises engaged in activities at all stages of the CP life cycle are determined. Innovative technological product. A model has been developed to improve the current regulatory and technical framework governing the CP turnover in Ukraine, and an algorithm for its implementation is presented. The relevance of methods and means of ensuring the quality, safety and effectiveness of CP by introducing quality management systems at all stages of its life cycle is determined. The scope of the innovative technological product. The developed proposals are recommended for implementation in the system of state regulation of the CP turnover in order to ensure its quality, effectiveness and safety for the health of consumers

Research of the activities of the enterprises of the perfume and cosmetic industry of Ukraine

The perfumery and cosmetic industry of Ukraine is distinguished by its dynamic development and makes a significant contribution to the country's economy. Several types of economic activities are involved in its functioning, including the development, research, production and sale of perfumery and cosmetic products, as well as the provision of cosmetic services to the population. The economic activity of each sector in the chain of creation, production and sale of cosmetic products / services determines both their individual success and the efficiency of the entire system as a whole. In this regard, the systematization and analysis of the indicators of economic activity of enterprises of each type of activity of the national cosmetic industry is an urgent task, the solution of which will reasonably determine the prospects for both the further development of this industry and the export potential of the Ukrainian economy as a whole. The aim of this work was to conduct a comprehensive study of the dynamics of the main indicators of Ukrainian enterprises of perfumery, cosmetic and related industries economic activity for the period 2010–2019 and determination of their development trends. The available data of the State Statistics Service of Ukraine, the Patent Office of Ukraine, as well as a database of scientific and professional publications publications were used as materials and methods. Retrospective, logical, research methods, as well as the method of content analysis were used. The results of a comparative analysis of the main indicators of the economic activity of business entities in the studied industry made it possible to establish trends in the development of this sector of the economy and substantiate the patterns observed at the present stage. Conclusions. The results of the study indicate that the production potential of the perfumery and cosmetic industry in Ukraine is promising, as well as significant opportunities for further development of the trade in these products and the provision of cosmetic services to the population

ON THE WAY TO QMS IMPLEMENTATION: THE MAIN MILESTONES AND ISSUES IN EMERGING ECONOMY

The aim of the research is to analyze typical problems in the implementation of quality management systems (QMS) on the basis of private production enterprises which operate in emerging economy context and to develop a rational strategic plan for the design and implementation of such a system, taking into account the experience of successful organizations. The main benefits of implementing QMS are presented. In the article it is recommended to consider the formation of QMS as a project with the appropriate stages of activities. The following positions are envisaged at the initiation stage: formalization of the decision on QMS implementation, appointment of project participants, project team training, as well as development of mission, vision, quality policy and QMS process structure. At the implementation stage, it is proposed to develop and approve QMS documents, as well as to implement an internal audit program. At the stage of project closure, it is advisable to put into operation the developed system and pass a certification audit in order to obtain a certificate of compliance with the requirements of ISO 9001. The article presents the structure, content, sequence and estimated duration of all the stages of the project, as well as the division of responsibilities between the project team members. Emphasis is placed on the main issues which can arise at different stages of such a project. In the paper the following range of issues was identified: inconsistency of QMS processes structure with the existing organizational structure of the enterprise; incorrect definition of the performance indicators for processes at different hierarchy levels; erroneous decisions in the internal documentation system organizing. In its turn, in the article the causes for the above-mentioned issues were identified, namely: insufficient motivation of project participants, lack of time or other necessary resources, unwillingness to change the current management system of the company, inconsistency of real goals with the stated ones, etc. In the article it is proposed to divide the main causes of issues into three basic groups: by project participants (personal), bureaucratic (systemic) and leadership (administrative). The authors propose a number of measures to minimize the risks of issues in the QMS implementation, and determine the distribution of areas of responsibility for these measures organizing

Body-weight gains in Blaberus craniifer cockroaches and the intensity of their infection with gregarines and nematodes

Intestinal parasites are considered to be able to hinder growth of the host animals, reducing the extent of food metabolism, damaging the intestines’ integrity by filling it with products of their metabolism. However, a long co-evolution can mitigate the negative impact of a parasite on the host organism. To study how parasites – nematodes Cranifera cranifera (Chitwood, 1932) Kloss, 1960 (Oxyurida, Thelastomatidae) and gregarines Protomagalhaensia granulosae Peregrine, 1970 and Blabericola cubensis (Peregrine, 1970) Clopton, 2009 (Eugregarinorida, Blabericolidae) – afffect the growth rates of cockroaches, we performed an experiment on 200 larvae of Blaberus craniifer Burmeister, 1838 (Blattodea, Blaberidae), varying in weight and age. We monitored changes in their body weight, intensity of food consumption, and after the experiment we counted gregarines in the midgut and nematodes in the hindgut. As a result, we found that 100% of the cockroaches were infected with two species of gregarines and one species of nematodes. The intestines of small cockroach larvae (weighing 300–400 mg) contained 16–18 specimens of gregarines on average. Large larvae had a weak tendency towards increase in the intensity of gregarine infestation. Similarly, there occurred changes in the intensity of nematode invasion: young larvae were infected on average by 8–10 specimens of nematodes and large larvae had an average of 12–14 nematodes. At the level of tendency, nematodes were observed to enhance the cockroaches’ growth rates following increase in intensity of the parasitic infection. We found that the two groups of parasites had no effect on one another: the number of gregarines had no effect on the number of specimens of nematodes and vice-versa, the number of nematodes had no effect on the number of gregarine specimens. Perhaps, this is related to different localizations of the parasites: gregarines for most of their life feed in the small intestine, while nematodes feed in the large intestine. Therefore, growth rates of the cockroaches in our experiment have not changed due to the parasites. This indicates minimization of negative effects of gregarines in the midgut and nematodes in the hindgut on the host’s life cycle, developed over long co-evolution

Аналіз та визначення перспектив розвитку ринку лікарських косметичних засобів в Україні

Aim. To determine and analyze the assortment of medicinal cosmetic products sold in domestic pharmacies in order to update the trends and ways of further development of this segment of the consumer market in Ukraine.Materials and methods. Scientific publications, electronic databases of the State Register of Medicinal Products of Ukraine, the weekly “Apteka” (Pharmacy) and the Compendium Guide, as well as the results of our own research were used as information materials. The sales data of pharmacies in the Eastern and Central regions of Ukraine in the period from January 2018 to January 2019 were analyzed. The methods of marketing analysis, analytical, comparative, content analysis and generalization of information were used.Results. The structure and features of the modern domestic market of cosmetic products sold in pharmacies have been studied. The range of dermatological medicines has been investigated; the segment of medicinal cosmetics has been analyzed, and its features have been determined depending on the manufacturer, form of release, the content of active substances for all product categories.Conclusions. Based on the results of systematizing the assortment of medicinal cosmetics at the consumer market of Ukraine the directions and prospects for further development of this segment of pharmaceutical products have been determined. The necessity of further development of the state control system over the turnover of medicinal cosmetic products has been substantiated in order to provide their quality and safety for the consumer health.Цель: определение и анализ ассортимента лекарственной косметической продукции, реализуемой в отечественных аптеках, с целью актуализации тенденций и путей дальнейшего развития этого сегмента потребительского рынка в Украине.Материалы и методы. В качестве информационных материалов использовали научные публикации, электронную базу информации Государственного реестра лекарственных средств Украины, еженедельник «Аптека», справочник «Компендиум», результаты собственных социологических исследований. Проанализированы данные продаж аптек Восточного и Центрального регионов Украины в период с января 2018 г. по январь 2019 г. Использованы методы маркетингового анализа, аналитический, сравнительный, метод контент-анализа, обобщения информации и прогнозирования.Результаты исследования. Изучена структура и особенности современного отечественного рынка косметической продукции, реализуемой в аптеках. Исследован ассортимент лекарственных средств дерматологического назначения; проанализирован сегмент лекарственных косметических средств, установлены его особенности в зависимости от формы выпуска и содержания действующих веществ для всех категорий такой продукции.Выводы. По результатам систематизации ассортимента лекарственных косметических средств на потребительском рынке Украины определены направления и перспективы дальнейшего развития этого сегмента фармацевтической продукции. Обоснована необходимость дальнейшего развития системы государственного контроля оборота лекарственных косметических средств с целью обеспечения их качества и безопасности для здоровья потребителя.Мета: визначення, аналіз та прогнозування змін асортименту лікарської косметичної продукції, що реалізується у вітчизняних аптечних закладах, для актуалізації тенденцій і шляхів подальшого розвитку цього сегмента споживчого ринку в Україні.Матеріали та методи. Як інформаційні матеріали використовували фахові наукові публікації, електронну інформаційну базу Державного реєстру лікарських засобів України, аналітичні публікації щотижневика «Аптека», довідник «Компендіум», результати власних соціологічних досліджень. Проаналізовано дані продажів продукції в аптеках Східного та Центрального регіонів України у період з січня 2018 р. по січень 2019 р. Застосовано методи маркетингового аналізу, а також аналітичний, порівняльний, метод контент-аналізу, узагальнення інформації та прогнозування.Результати досліджень. Вивчено структуру та особливості сучасного вітчизняного ринку косметичної продукції, що реалізується в аптечних закладах. Досліджено асортимент лікарських засобів дерматологічного призначення; проаналізовано сегмент лікарських косметичних засобів та встановлено його особливості залежно від форми випуску, вмісту діючих речовин для усіх категорій продукції.Висновки. За результатами систематизації асортименту лікарських косметичних засобів на споживчому ринку України визначено напрями й перспективи подальшого розвитку цього сегмента фармацевтичної продукції. Обґрунтовано необхідність подальшого розвитку системи державного контролю обігу лікарських косметичних засобів з метою забезпечення їх якості і безпеки для здоров’я споживача

Аналіз функціонування процесу внутрішнього аудиту на вітчизняних фармацевтичних підприємствах

Aim. To analyze the internal audit process functioning at the domestic pharmaceutical companies by elaborating the results of a sociological survey of representatives of the profile divisions of these companies.Materials and methods. The research objects were domestic pharmaceutical companies with the license to manufacture and sale of medicinal products on theterritory ofUkraine, and with the certificates of compliance with the requirements of the standard ISO 9001 or other standards for management systems. In the paper the information materials from the open source were also used.Results. The topical issues of the domestic pharmaceutical companies when organizing and conducting internal audits of the quality management systems were identified, the main ways of their solution were substantiated.Conclusions. The study conducted has shown that there are facts of the insufficient effectiveness of internal audits at domestic pharmaceutical companies. This suggests that development of the scientifically based proposals for the organizational and methodological framework reform on the audit activity is a topical and important area of the future research.Цель: анализ функционирования процесса внутреннего аудита на отечественных фармацевтических предприятиях на основе обработки результатов социологического опроса представителей профильных подразделений этих предприятий.Материалы и методы. Объектами исследования были отечественные предприятия фармацевтической сферы, имеющие лицензию на производство и торговлю лекарственными средствами на территории Украины, а также имеющие сертификаты соответствия требованиям стандарта ISO 9001 или других стандартов на системы менеджмента. В работе также применялись информационные материалы из источников обнародованной информации.Результатами исследования стали определение актуальных проблем, с которыми сталкиваются отечественные фармацевтические предприятия при организации и проведении внутренних аудитов систем управления качеством, и обоснование основных путей их решения.Выводы. Исследование выявило наличие фактов недостаточной результативности внутренних аудитов на отечественных фармацевтических предприятиях. Это свидетельствует, что разработка научно обоснованных предложений по реформированию организационно-методических основ осуществления аудиторской деятельности – актуальное и важное направление исследований.Мета: аналіз стану функціонування процесу внутрішнього аудиту на вітчизняних фармацевтичних підприємствах через опрацювання результатів соціологічного опитування представників профільних підрозділів таких підприємств.Матеріали та методи. Об’єктами дослідження були вітчизняні підприємства фармацевтичної сфери, які мали ліцензію на виробництво й торгівлю лікарськими засобами на території України, а також мали сертифікати відповідності вимогам стандарту ISO 9001 чи інших стандартів на системи управління. У роботі також застосовувалися інформаційні матеріали джерел оприлюдненої інформації.Результатами дослідження стало визначення найбільш актуальних проблем, з якими стикаються вітчизняні фармацевтичні підприємства при організації й проведенні внутрішніх аудитів систем управління якістю, та обґрунтування шляхів їх подальшого вирішення. Висновки. Дослідження показало наявність фактів недостатньої результативності внутрішніх аудитів на вітчизняних фармацевтичних підприємствах. Це свідчить, що розробка науково обґрунтованих пропозицій щодо реформування організаційно-методичних засад здійснення аудиторської діяльності є актуальним і важливим напрямком подальших досліджень.

Introduction of a Quality Management System at an Industrial Enterprise: Problems and Risks

The purpose of the article is to substantiate a sound plan to design and implement a quality management system (QMS) at a typical domestic industrial enterprise: from the pre-design phase to obtaining a conformity certificate; to highlight problems that arise during the implementation of QMS, and to suggest sound recommendations for their solution. The introduction of QMS is considered as a project with the appropriate stages: the initiation stage, which means making decision on introducing QMS and appointing the project manager and task group; the planning stage, which means training the task group, defining the mission, vision, and policy in the field of the company quality, and designing the structure of QMS processes; the implementation stage, which means creating and publishing QMS documents and those of the pre-certification internal audit cycle; the completion stage, which means implementing all the documented procedures designed, and obtaining a certificate of their compliance with the requirements of ISO 9001 standart. The stages of such a project, their sequence, the estimated duration and distribution of responsibilities between the persons involved are offered. Possible problems arising at various stages of such a project are considered, namely: the conflict of QMS processes structure with the existing organizational set-up; unification of terms in the QMS processes structure due to the terminology already existing in the internal documentation; vague definition or lack of performance indicators; difficulties with the creation of the documentation system. Among the causes of these problems are: lack of motivation, unprofessionalism and / or lack of time among the developers, attempts to adapt to the existing system, the inconsistency of the actual goals of the organization head with the declared ones. It is recommended to divide the problem areas into three groups: by the performers (personal ones), by the system (systemic ones) and by the management of the company (administrative or leadership ones). A number of measures to eliminate or minimize the risks of problems arising during the introduction of QMS are suggested, and the responsibility areas as for taking these measures are determined

Організація оглядів функціонування системи управління якістю фармацевтичного підприємства

Aim. To determine the state of organizing the process of analyzing the quality management system of a typical pharmaceutical enterprise in accordance with the current industry requirements of Good Manufacturing Practice and the ISO 9001:2015 standard, as well as substantiating effective approaches to improving this activity. Materials and methods. We used analysis, comparison, questionnaires, surveys and direct observations. The results were processed and verified using licensed Microsoft Office Excel software products. Results. The relevance of the development of quality management systems (QMS) of domestic pharmaceutical organizations in the period of martial law has been proven. The requirements of the DSTU ISO 9001:2015 standard, as well as the requirements of the guidelines on Good Manufacturing Practice (GMP) of medicines for reviewing and analyzing QMS of pharmaceutical enterprises (PhE) have been analyzed. Approaches to the organization of QMS review at a number of domestic PhE have been studied; as a result, typical inconsistencies of these procedures have been determined. Based on the results of the study and the experience analyzed in supporting the QMS functioning of PhE, effective organizational approaches have been identified, and recommendations are given for the effective analysis of QMS of PhE. Conclusions. In the study conducted, a review of the practice of analyzing QMS at a number of domestic and foreign PhE has been carried out, and typical inconsistencies of this process have been identified and systematized. The requirements of the DSTU ISO 9001:2015 standard, as well as the industry requirements of the GMP guidelines for reviewing and analyzing the quality system of PhE have been analyzed. Based on the results of the research and the authors’ own experience in implementing and supporting the QMS functioning of PhE, the main organizational approaches and recommendations for analyzing QMS of PhE have been determined.Мета – визначення стану організації процесу аналізу системи управління якістю типового фармацевтичного підприємства відповідно до чинних галузевих вимог належної виробничої практики та стандарту ISO 9001:2015, а також обґрунтування ефективних підходів щодо удосконалення цієї діяльності. Матеріали та методи: аналіз, зіставлення, порівняння, анкетні опитування та безпосередні спостереження. Оброблення результатів і з’ясування їх достовірності проводились за допомогою ліцензованих програмних продуктів Microsoft Office Excel. Результати дослідження. Доведено актуальність розвитку систем управління якістю (СУЯ) вітчизняних організацій фармацевтичної сфери у період воєнного стану. Проаналізовано вимоги стандарту ДСТУ ISO 9001:2015, а також вимоги Настанови з належної виробничої практики лікарських засобів (GMP) до огляду й аналізу СУЯ фармацевтичних підприємств (ФП). Досліджено підходи до організації аналізування СУЯ на деяких вітчизняних ФП, за результатом чого визначено типові невідповідності цих процедур. На основі результатів дослідження та проаналізованого досвіду стосовно підтримки функціонування СУЯ ФП визначено дієві організаційні підходи й надано рекомендації стосовно результативного аналізу СУЯ ФП. Висновки. У ході проведеного дослідження було здійснено огляд практики аналізу СУЯ на деяких вітчизняних і закордонних ФП, визначено й систематизовано типові невідповідності цього процесу. Проаналізовано вимоги стандарту ДСТУ ISO 9001:2015, а також галузеві вимоги настанови з GMP щодо огляду й аналізу системи якості ФП. На основі результатів дослідження та власного досвіду авторів стосовно запровадження й підтримки функціонування СУЯ ФП визначено основні організаційні підходи й рекомендації щодо аналіз СУЯ ФП