Quality Of Medicinal Products Research Articles

Current and Future Pharmacopoeial Requirements for the Quality of Extemporaneous Medicinal Products: A Review of Regulatory Standards

INTRODUCTION. The organisation of extemporaneous compounding in pharmacies is currently considered to be a priority for the national healthcare system. Extemporaneous medicinal products used by patients should meet high quality, safety, and efficacy standards. Provision of consistent and science-based requirements for the quality of medicines, particularly those compounded in pharmacies, is a key area of concern for standardisation.AIM. This study aimed to analyse international experience and determine areas for the improvement of standardisation approaches of the State Pharmacopoeia of the Russian Federation to the quality of medicinal products compounded in pharmacies.DISCUSSION. The study investigated the common and distinctive properties of extemporaneous preparations compounded in pharmacies (and not subject to registration) and medicinal products manufactured by pharmaceutical companies. The authors analysed the requirements and recommendations for compounding and quality assurance of extemporaneous medicinal products provided by the regulatory and pharmacopoeial authorities of the Russian Federation, the Republic of Belarus, the European Union, the United Kingdom, the USA, and Canada. The United States Pharmacopeia includes circa 150 individual monographs for non-sterile compounded drug products with particular compositions and over 20 individual monographs for sterile compounded drug products. The European Pharmacopoeia requires that extemporaneous preparation should be organised within the quality assurance framework of a pharmacy after a proper risk assessment. In the Republic of Belarus, extemporaneous medicinal products are compounded in line with the requirements of the Good Compounding Practices and the State Pharmacopoeia of the Republic of Belarus, which provide rapid testing procedures for extemporaneous medicinal products.CONCLUSIONS. The study identified the following areas for the development of requirements for the quality of medicinal products compounded in pharmacies: the determination of rapid testing approaches; the development of pharmacopoeial monographs for active pharmaceutical substances used in extemporaneous compounding, with the Identification section supplemented with an additional subsection on pharmacy-specific analytical procedures; and the development of pharmacopoeial monographs for frequently used compounding formulae.

Botanical and pharmacognostic investigation of Strobilanthes kalimantanensis.

Under a hidden waterfall in the interior of the tropical rainforest of East Kalimantan, a new medicinal plant that produces essential oil (EO) was found with the name Strobilanthes kalimantanensis. The aim was to investigate the botanical and evaluate the pharmacognostic characteristics of S. kalimantanensis leaves from East Kalimantan, Indonesia. Pharmacognostic studies can provide recommendations for establishing quality control standards or guidelines for cultivating, harvesting, and processing S. kalimantanensi s to ensure the consistent and reliable quality of medicinal products. Characteristic methods of S. kalimantanensis leaves include botanical macroscopic, fluorescence, physicochemical, and phytochemical evaluation. The plant characteristics of this plant are similar to S. kunthia and S. reptans but can be differentiated in the leaves and flowers. Fluorescence assay with sodium hydroxide 5% shows unique characteristics of secondary metabolites based on their ability to form dark green with black precipitate in Ultraviolet 365 nm. The physicochemical characteristics showed yield, water content, water-soluble, ethanol soluble, total ash value, and acid-insoluble ash. Phytochemicals showed the presence of alkaloids, polyphenols, terpenoids, and EO containing 23% trans-anethole. This evaluation report details the chemical composition, identity, and safety of S. kalimantanensis leaves.

APPLICATION OF MODERN METHODS OF ANALYSIS FOR DETERMINATION OF POLLUTION AND IDENTIFICATION OF PLANT RAW MATERIALS

Quality control of herbal preparations is an important component to ensure the effectiveness and safety of their use. Phytochemical medicines are made from medicinal plant materials that may contain unwanted chemical compounds, so careful quality control must be performed to ensure their safety and efficacy. The success of quality control of herbal materials requires an integrated approach, i.e. a combination of various techniques and methods that allow analyzing the main classes of compounds. Various methods of analysis are used to overcome these difficulties. Today, the main chemical methods for determining the quality of medicinal products are chromatographic, in particular gas chromatography (GC), often combined with mass spectrometry (MS), liquid chromatography (HPLC), thin-layer chromatography (TLC), column chromatography (CC). Besides, HILIC is the optimal method for the analysis of polar and ionized compounds that are too strongly retained on polar stationary phases and/or poorly separated by standard chromatographic methods. TLC/HPTLC methods are traditionally used by the SPhU and the European Pharmacopoeia for identification of herbs and detection of impurities by visual assessment, as well as for semi-quantitative determination of compounds when comparing the intensity of the spot in the zone of the tested solution with spots in the zones of reference compounds. The mentioned methods have still remained the most acceptable for the identification of herbs, which is explained by the unique chromatographic profile of each plant or extract based on it. At the same time, the instrumental method of HPLC has advantages due to the possibility of quantitative determination of substances that fluoresce in UV or visible light. Nowadays, the direction of scientific research devoted to the optimization of the previously described analytical methods and the development of new ones for the identification of both herbs and herbal materials, as well as herbal remedies, becomes relevant. In addition, the development of methods for the quantitative determination of herbal compounds is a relevant scientific and practical direction.

Storage and time course effects on the quality of oil extracted from Phyllanthus amarus Schumach and Annona muricata Linn and their antidiabetic potentials.

With the advent of modern technology, advancements in processing and storage techniques, and increasing medical knowledge, people are becoming aware of deterioration in the quality of medicinal products due to storage methods and time. In most cases, herbal products are not consumed immediately after production; as such, improper storage can result in physical, chemical, and microbiological changes. The study evaluated the effect of storage methods and time on the quality of oil extracted from Phyllanthus amarus Schumach and Annona muricata Linn and assessed their antidiabetic and antioxidative effects. Plants were air-dried, pulverized, and then subjected to Soxhlet extraction in petroleum ether. The oil was evaluated for phytochemical constituents and the effects of time and storage methods on its physicochemical properties. Characterization of the oil was done by spectroscopic techniques. Oils from both plants contained tannins, flavonoids, alkaloids, steroids, glycosides, terpenoids, phlobotannins, resins, reducing sugar, phenols, and saponins in different proportions. The oil from A. muricata had higher phenolic (3.11 ± 0.31 mg GAE/g), flavonoid (11.82 ± 0.08 mg QUE/g), alkaloid (16.37 ± 0.56 mg APE/g), and tannin (7.13 ± 0.47 mg CE/g) contents than the oil from P. amarus, which had 0.54 ± 0.08 mg GAE/g, 7.83 ± 0.13 mg QUE/g, 9.87 ± 0.15 mg APE, and 3.16 ± 0.12 mg CE/g for total phenolic, flavonoids, alkaloids, and tannins, respectively. Initial acid, iodine, peroxide, and saponification values recorded for P. amarus were 5.63 ± 0.82 mg KOH/g, 97.17 ±0.53 Wijis, 9.31 ± 0.15 mEq/kg, and 116.11 ± 0.74 mg KOH/g, respectively, significantly different from those of A. muricata , which had values of 1.17 ± 0.08 mg KOH, 76.23 ± 0.03 Wijis, 6.75 ± 0.47 mEq/kg, and 193.31 ± 0.52 mg KOH/g, respectively. FT-IR characterization of the oils revealed the presence of carboxylic acid, alkyl, alkene, alkane, haloalkane, aldehyde, aromatic amine, α-unsaturated and β-unsaturated esters, and phenol functional groups. P. amarus oil inhibited α-amylase (IC50 0.17 ± 0.03 mg/ml), α-glucosidase (IC50 0.64 ± 0.03 mg/ml), and xanthine oxidase (0.70 ± 0.01 mg/ml) to a greater extent than A. muricata oil, with IC50 values of 0.43 ± 0.05 mg/ml (α-amylase), 2.25 ± 0.31 mg/ml (α-glucosidase), and 0.78 ± 0.07 mg/ml (xanthine oxidase). This study showed that oils from the tested plants have low rancidity with a moderate shelf life. The extracts contained essential phytoconstituents that significantly inhibited α-glucosidase and xanthine oxidase. These effects of the oil indicate their potential to prevent diabetes, gout, and oxidative stress. Consequently, the supply of P. amarus and A. muricata in homemade diets is strongly encouraged for healthy living.

PRACTICAL CLASSES AS A FORM OF COMPETITIVE PHARMACY SPECIALIST TRAINING

In the article, in line with the tasks of forming the organizational and managerial culture of masters of pharmacy based on the concept of the development of the pharmaceutical industry as an integral component of the country’s health care system, the goal is realized. It is to clarify the role of practical classes as the leading organizational form of the educational process of training highly qualified personnel who develop and implements a modern system of ensuring the quality of medicinal products, has not only fundamental knowledge of physics, chemistry, biology, scientific management, special disciplines, but also has an extensive system of practical skills and professional activity skills.
 On the basis of the general pedagogical principle of the unity of theory and practice, practical training is characterized as the leading organizational form of the educational process of professional training of pharmacy managers, which has its own objectives, intended for the development of students’ professional and practical skills necessary for specialists to perform their duties relationships and formation of professional and business qualities of graduates of the master’s level of education.
 The works of Ukrainian scientists in terms of types, structure, methods of conducting, specifics of training teachers and students for practical classes of various forms and types are adapted to the needs of a specific field of specialist training.
 It was concluded that the intensification of the educational process stimulates the use of advanced learning technologies accumulated by practice by teachers in practical classes. Practical classes are conducted using the elements of discussion, business game, "brainstorming", dyadic form of work of applicants (performance of tasks to consolidate the material in pairs, control of knowledge, evaluation of completed actions and tasks), etc. The summary of the results of a practical session with future pharmacists is often in the form of a colloquium, where the candidates announce their written results and briefly explain them. You can participate in the discussion of the proposed decision by expressing your opinion, motivating and arguing it.

COUNTERFEIT AND ILLEGAL MEDICINAL PRODUCTS AS AN EXAMPLE OF DRUGS THAT DO NOT MEET THE BASIC QUAITY REQUIREMENTS

Falsification or counterfeiting of medicinal products is a severe pharmaceutical crime. According to the World Health Organization, about 10% of medicinal products in developing countries are falsified. In the case of medicines sold over the Internet, the figure is as high as 50%, and this phenomenon's scale is increasing yearly. The illegally sourced preparations are not manufactured in accordance with Good Manufacturing Practice (GMP). Among the most frequently falsified medicinal products are preparations used for erectile dysfunction, weight loss aids, or anabolic-androgenic steroids. The presence of undeclared active ingredients and impurities, incorrect dosage due to different than declared contents, and the sourcing of over-the-counter medicines from unknown sources can lead to serious side effects that threaten patients' lives and health. In addition, inaccurate or incomplete descriptions of product formulation can additionally cause the risk of drug interactions, which can consequently lead to serious medical incidents.
 The purpose of this paper is to discuss the requirements for medicinal products and to present the problem of the quality of counterfeit and illegal medicinal products. This issue is discussed using phosphodiesterase type 5 inhibitors (applied to the treatment of erectile dysfunction) as an example.
 KEYWORDS: falsified medicinal products, quality of medicinal products, PDE-5 inhibitors

Using Shewhart charts to monitor quality characteristics of preventive vaccines for tuberculosis

Scientific relevance. The quality of medicinal products, particularly vaccines, is contingent on the stability of the manufacturing process at all stages, which can be evaluated using Shewhart charts for data obtained by monitoring the quality attributes of interest.Aim. This study evaluated the stability of the quality and manufacturing processes of the BCG and BCG-M tuberculosis vaccines using Shewhart charts.Materials and methods. This study focused on samples of the BCG tuberculosis vaccine and the BCG-M tuberculosis vaccine, a less reactogenic alternative for primary immunisation. Both vaccines were released to the market in 2019–2022. The quality of samples was assessed for stability based on their potency and total bacterial count, which are the key parameters for immunogenicity evaluation. These quality parameters were compared using test results submitted by the manufacturer and obtained at the testing centre. The authors plotted individuals charts (X-charts) and moving range charts (R-charts) in accordance with national standards GOST R 50779.42-99 and GOST R ISO 7870-2-2015.Results. The quality of the BCG and BCG-M vaccines remained stable during the entire follow-up period (2019–2022). For some periods, the retrospective analysis of R- and X-charts revealed characteristic trends meeting special cause criteria. The Pearson correlation coefficient (r) between the data submitted by the manufacturer and the data obtained at the testing centre ranged from 0.2 to 0.8.Conclusions. The Shewhart charts demonstrated that the quality parameters of the BCG and BCG-M tuberculosis vaccines tested in 2019–2022 were stable. These vaccines had stable manufacturing processes, as shown by the R- and X-charts. However, the warning signs indicated that additional measures should be taken to standardise the manufacturing processes. The findings suggest that Shewhart charts may be recommended for monitoring the production and quality of tuberculosis vaccines.

Analytical Quality by Design-Compliant Development of a Cyclodextrin-Modified Micellar ElectroKinetic Chromatography Method for the Determination of Trimecaine and Its Impurities.

In 2022, the International Council for Harmonisation released draft guidelines Q2(R2) and Q14, intending to specify the development and validation activities that should be carried out during the lifespan of an analytical technique addressed to assess the quality of medicinal products. In the present study, these recommendations were implemented in Capillary Electrophoresis method development for the quality control of a drug product containing trimecaine, by applying Analytical Quality by Design. According to the Analytical Target Profile, the procedure should be able to simultaneously quantify trimecaine and its four impurities, with specified analytical performances. The selected operative mode was Micellar ElectroKinetic Chromatography employing sodium dodecyl sulfate micelles supplemented with dimethyl-β-cyclodextrin, in a phosphate-borate buffer. The Knowledge Space was investigated through a screening matrix encompassing the composition of the background electrolyte and the instrumental settings. The Critical Method Attributes were identified as analysis time, efficiency, and critical resolution values. Response Surface Methodology and Monte Carlo Simulations allowed the definition of the Method Operable Design Region: 21-26 mM phosphate-borate buffer pH 9.50-9.77; 65.0 mM sodium dodecyl sulfate; 0.25-1.29% v/v n-butanol; 21-26 mM dimethyl-β-cyclodextrin; temperature, 22 °C; voltage, 23-29 kV. The method was validated and applied to ampoules drug products.

Pharmaceutical Analysis in Drug Discovery and Drug Development

Pharmaceutical analysis stands as a linchpin within the intricate and multifaceted landscape of drug development. It assumes a pivotal role in upholding the safety, efficacy and quality of medicinal products at each juncture of their odyssey from conceptualization to market integration. Within this discourse, we delve into the paramount role of pharmaceutical analysis within the sphere of drug development. Pharmaceutical analysis plays an instrumental role in the identification and characterization of lead compounds that harbor therapeutic potential. Techniques such as high-throughput screening, mass spectrometry and nuclear magnetic resonance (NMR) serve as guiding lights in the quest for promising candidates. The elucidation of molecular structures through the means of NMR and X-ray crystallography takes center stage, facilitating a profound comprehension of the intricate interplay between drugs and biological targets. In this review we focused on role of pharmaceutical analysis in drug development and drug discovery. Inadequate pharmaceutical analysis and manufacturing practices can lead to the distribution of unsafe and ineffective medicines. Thus, adherence to cGMP is not only a legal obligation but also a moral imperative to protect public health and maintain the integrity of the pharmaceutical industry.

Situation analysis on the regulation of nanomedicines in Southern Africa.

Medical products incorporating nanoparticle drug delivery systems (nanomedicines) are therapeutic or imaging agents, which comprise a delivery system within the nanometer size range (1 - 1000 nm). As medical products, nanomedicines meet definitions of medicines according to various national legislations for regulation of medicines. However, for the regulation of nanomedicines, additional assessments including toxicological issues have to be considered. These complexities require extra regulatory effort. In the resource-limited context of low- and middle-income countries, many National Medicines Regulatory Authorities (NMRAs) lack resources and capacities to effectively assure the quality of medicinal products in their countries. With emerging trends in innovative technologies, including nanotechnology, this burden is worsened. The need to overcome regulatory challenges drove the formation of a work sharing initiative in the Southern African Development Community (SADC), ZaZiBoNA in 2013. Regulatory agencies participating in this initiative cooperate in the assessment of applications for registration of medicines. A cross-sectional exploratory study design with qualitative techniques was used to investigate the status of the regulation of nanomedicines in Southern African countries in particular those participating in the ZaZiBoNA initiative. The study found that in general, NMRAs are aware of the existence of nanomedicines and they apply legislation applicable to other medical products. The NMRAs however neither have specific definition for nanomedicines and technical guidance documents, nor technical committees specific for consideration of nanomedicines. Collaboration with external experts or organisations in the regulation of nanomedicines was also found to be lacking. Capacity building and collaboration in the area of regulation of nanomedicines is strongly encouraged.

Certified Reference Material of Tylosin Tartrate

To date, antibiotics are often used in the treatment of infectious diseases in medicine and veterinary medicine, as well as growth promoters in animal husbandry. The uncontrolled use of antibiotics leads to antibiotic residues in food products that are easily transmitted to humans through food chains. Due to these undesirable effects, as well as in connection with the circulation of substandard and counterfeit medicinal products, it is necessary to control the quality of medicinal products, as well as monitor the food safety of animal products by determining the content of drug residues using reference materials (RMs).The aim of this research was to develop a CRM for the composition of tylosin tartrate.In the course of the research, a method for preparing the initial RM was tested and successfully implemented, a critical analysis of methods for measuring the content of tylosin tartrate was carried out, and the choice of the HPLC method as the main method for quantitative determination of the certified value of the measured quantity (mass fraction of tylosin) was justified. The disadvantages of the microbiological method and the titrimetry method as alternative methods were shown. In accordance with RMG 93–2015 and GOST ISO Guide 35–2015, the standard uncertainty of the RM certified value from the characterization method, heterogeneity and instability of the material was estimated. The expanded uncertainty of the certified value was calculated. The result of the work performed was the approval of a new type of the CRM for the composition of tylosin tartrate GSO 11632 2020.Normalized metrological characteristics: the mass fraction of tylosin is 800–1100 µg/mg, the relative expanded uncertainty at k = 2, P= 0.95 is 6%. The CRM is stored in sealed ampoules separately from food and feed in a dry and dark place at a temperature from plus 4 °C to minus 18 °C, the shelf life of the CRM is 4 years.The practical significance of the results obtained makes it possible to expand the possibility of certification of measurement methods and control of the accuracy of the measurement results of the mass fraction of tylosin in veterinary medicinal products, food and food raw materials, animal feed, and environmental objects. The CRM can also be used to identify tylosin in medicinal products and to determine the susceptibility of pathogens to tylosin.

A Review on Modern Trends in Analytical Instruments

Pharmaceutical analysis stands as an essential cornerstone within the pharmaceutical sector, playing a critical role in upholding the safety, effectiveness and quality of medicinal products. This scientific discipline encompasses a range of techniques for scrutinizing pharmaceutical compounds, dosage formulations and associated materials, with its primary mission being the fulfilment of regulatory standards and the preservation of public well-being. In this review, we mainly focussed on the modern trends in analytical instruments that include miniaturization & portable devices, multimodal & hybrid instruments, high resolution imaging techniques, data driven approaches, spectroscopy advancements, mass spectrometry innovations, advancements in chromatography, emergence of electrochemical sensors and nanotechnology integration. In pharmaceutical analysis, the horizon of innovation and transformation is being explored with enthusiasm and determination. The visionaries of this evolving landscape are the dedicated pharmaceutical analysts, scientists and researchers. They are at the forefront of pioneering the advancements that promise to reshape drug development, quality control and healthcare.

30 років національній системі стандартизації, метрології і контролю якості лікарських засобів в Україні: основні досягнення, проблеми і перспективи розвитку

Provision to every citizen, patient, and person in the system of legal relationship "doctor-patient-pharmacist" the right to life, health, and safety during the circulation of vital medicinal products of all clinical and pharmacological, nomenclature and legal, classification and legal groups, guaranteed by created in in Ukraine the system of standardization and quality control of medicines. The system of standardization and quality control of medicines includes the National System of Standardization of Medicines in Ukraine (1992); The system of state control of the quality of medicinal products (1992); Programs for the development of generic drugs in Ukraine (1995); The school of standardization and quality control of medicinal products; Center for standardization, metrology, and quality control in Ukraine. Ukraine got observer status in the European Pharmacopoeia in 1998. The National Pharmacopoeia of Ukraine (2001) appeared 6-7 years earlier than other countries (Belarus, Kazakhstan, Russian Federation). Two editions of the State Pharmacopoeia of Ukraine, totaling thirteen volumes and 7,208 pages, was developed as of 2022 and put into effect. The State Pharmacopoeia of Ukraine is fully harmonized with the European Pharmacopoeia and is the basis of the entire system of standardization and quality control of medicinal products in Ukraine. A pharmacopeial language (Ukrainian terminological apparatus), which did not exist before, was developed, and implemented. The State Pharmacopoeia of Ukraine is an important reference-informational and educational-methodical material for pharmaceutical enterprises, health care institutions, pharmacies, universities of medical and pharmaceutical profiles. The national system of pharmacopeial standard samples largely meets the needs of national control laboratories, and ranks the 6th in the world in terms of the number of pharmacopeial standard samples. The State Pharmacopoeia of Ukraine is the only pharmacopoeia in the world in which standardized validation procedures have been introduced, which has turned validation into an ordinary routine procedure. Ukraine acquired the status of a full member of the European Pharmacopoeia in 2013. European standards for the quality of medicinal products are in force in Ukraine. The State Pharmacopoeia of Ukraine acquired voting membership in the Pharmacopoeia of the United States in 2010. In order to develop texts that are not in the European Pharmacopoeia (in particular, monographs on ready medicines), the State Pharmacopoeia of Ukraine concluded Agreements with the leading pharmacopoeias of the world – the USA in 2010 and Great Britain in 2013. A powerful market, world- and European-level pharmaceutical industry was created, which was included in the field of health care, which provided the pharmacy network and health care institutions with modern, effective, safe, high-quality, and economically available drugs. The system of legal relations "doctor-patient-pharmacist" is based on the principles of pharmaceutical law, the Constitution of Ukraine, laws, and regulatory acts, timely ensures the right of a person, citizen, and patient suffering from various health disorders in accordance with the ICD-11, on life and health.

Сучасні пріоритети формування фармацевтичного ринку України в контексті забезпечення якості лікарських засобів

The article studies the current state of the pharmaceutical market of Ukraine in the context of ensuring the quality of medicinal products and preventing the spread of falsified medicinal products. It is found that according to the State Register of Medicinal Products of Ukraine, 13.664 drugs were registered in October 2020. It is further found that today in the structure of the assortment of medicines in the pharmaceutical market of Ukraine, foreign drugs make up more than 70%, and in certain classification groups they reach 90%. It is determined that the main importers of medicines to Ukraine are Germany, India, France, Italy, Slovenia and Hungary. It is specified that Ukraine practically does not have its own production of active pharmaceutical ingredients (APIs), about 80% of APIs is imported from China and India, therefore distributors are mainly responsible for the quality of APIs. It is found that in the period from 2000 to 2020, the State Drug Inspectorate annually detected and removed from circulation circa 4–117 series and 3–63 names of falsified medicinal products. It is determined that the counterfeiting and underground production of falsified medicinal products in 2017–2020 on the territory of Ukraine were detected both by the State Medical Service and law enforcement agencies. It is further determined that in 2017 the State Medical Service issued 18 orders prohibiting the circulation of falsified medicinal products, in 2018 – 11 respective prohibiting orders, in 2019 – 21, and in 2020 – 4 respective prohibiting orders. It is specified that over the past 10 years there has been a steady trend towards an increase in the number of falsified medicinal products in the pharmaceutical market of Ukraine. The main factors stimulating the circulation of falsified medicinal products have been established: the unstable economic situation in Ukraine; a developed system of online sales of medicines; the shortage of medicines creates the possibility of distribution of falsified medicines; high drug prices when compared with the average paying capacity of the population, as well as a large difference in market prices, which stimulates the sale of a cheaper counterfeit drug.

Significance of Personnel Hygiene Practices in Pharmaceutical Industry

Personnel hygiene is very important in the pharmaceutical industry to prevent or reduce any kind of contamination which can affect the quality of medicinal products. When it comes to delivering highest quality standards of pharmaceutical products, key hygiene factors must to be upheld. Good personnel hygiene policies and practices are the foundation for successful product safety and purity. They are the backbone of a meaningful Good manufacturing Practices (GMP). Proper personnel training and sanitation are of prime importance. Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. All personnel should undergo medical check-up which may be a prerequisite for safe working condition. Personnel hygiene policies and procedures are to be followed by all personnel including management, visitors, production, sanitation and maintenance staff, for reducing the chance of product contamination. Personnel hygiene practices and procedures play a vital role in pharmaceutical industry in order to achieve a good quality and safe product.

약선요리 품질속성이 소비자 만족도 및 구매태도에 미치는 영향

The recent domestic dining out consumption trend is developing into a well-being type of dining out culture that contains emotional values that combine taste, fashion, and pleasure. Therefore, the paradigm of eating out culture is changing to improve the quality of life of consumers. This change has been shown by consumers' interest in well-being and well-being food that pursues a healthy and happy life. The purpose of this study was to empirically verify the effects between quality attributes, satisfaction, and purchasing attitude on medicinal cuisine targeting consumers who are interested in or have experienced medicinal cuisine. This survey conducted a survey of 248 consumers who were interested in or experienced medicinal cuisine. The main research results of this study are summarized as follows, focusing on hypothesis verification. First, as a result of analyzing the effect of the pharmacological quality attribute on consumer satisfaction, it was found that the pharmacological action and cooking selection attribute had a significant positive effect on satisfaction, and the nutritional quality attribute did not significantly affect satisfaction. Second, as a result of analyzing the effect of consumers' satisfaction with the quality of medicinal products on the purchase attitude, it was found that the consumer's satisfaction had a significant positive effect on the purchase attitude. Third, as a result of analyzing the effect of the medicinal food quality attribute on the consumer's purchasing attitude, it was found that the pharmacological action and cooking selection attribute had a significant positive effect on the purchasing attitude, and the nutritional quality attribute did not.

ACTUAL PROBLEMS OF PROFESSIONAL AND PERSONAL DEVELOPMENT QUALIFIED PERSONS RESPONSIBLE FOR QUALITY OF MEDICINAL PRODUCTS FOR HUMAN USE

The aim of the study is to investigate topical problems of the professional and personal development of qualified persons responsible for quality of medicinal products for human use.Materials and methods. In the period from April 6 to May 10, 2020, an online survey of leading employees in the field of quality assurance of Russian manufacturers was conducted. 176 people took part in the survey; the return of questionnaires was about 17.9%.Results. From the standpoint of D. Super’s theory of professional development, the largest number of respondents was at the maintenance stage, holding their achieved positions (53.2%). All respondents, regardless of age, were motivated for professional development. Most often qualified persons had chemical engineering (27.3%) and pharmaceutical education (22.2%). Most of them had a working experience in 1–2 divisions of the enterprise, and combined the functions of qualified persons with managerial positions (74.5% and 71.9%, respectively). The majority of the qualified persons (86.4%) indicated the sufficiency of the available knowledge and the lack of knowledge on certain issues. Knowledge and skills in the quality risk management, specific GMP issues and statistical methods (59.0%, 49.2 and 44.2%, respectively); communication and interpersonal skills and, in particular, stress management, emotion management and the art of negotiation (49.4%, 41.3% and 40.9%, respectively), were most popular. About 36% of respondents notified the need for the digital economy competencies, while only 5.1% notified the presence of an electronic batch production record at the enterprise. Finally, only half of the respondents (50.5%) had a formal training plan for qualified persons.Conclusion. This pilot study revealed the need for the revision of the Exemplary Additional Professional Training Program for Qualified Persons and the professional standard, the urgent need for the regulatory body to develop a scheme and principles for the continuous professional development of qualified persons, and showed the direction of further research in this area.

Improving the Quality of Medicinal Products by a Microencapsulation Method

The possibility of the enhancing the bioavailability, increasing the shelf life, and improving the organoleptic properties of finished pharmaceuticals using microencapsulation is reviewed. Predetermined properties, including gradual supply of the active ingredient into the blood pool, can be highly reliably provided.

Establishment of Microbial Limit Test for Hospital Preparation ‘Compound Alum Powder’

Background: the assessment of microbiological quality of medicinal products is one of control stages in medicinal products saft, because the holder of a manufacturing authorization must drug so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy. Objective: To assess microbial limit test for hospital preparation ‘compound alum powder’. Methods: The results of strain culture and analysis were used to evaluate the drug quality of ‘compound alum powder’. The objective is ‘compound alum powder’ (approval number: Z20140229) was made by the First Affiliated Hospital of Jinan University. Their batch numbers include: 201019, 200818, 200701. Validation tests were carried out in accordance with the standards of the Chinese Pharmacopoeia (2020 edition). Three parallel independent validations were conducted to calculate the recovery rate of each test bacterium and investigate whether each test bacterium was detected in the control bacterial inspection. Result: The recovery ratio of the total number of aerobic bacteria, molds and yeast in the control group was in the range of 0.5 ~ 2, and the results of the control group were positive, and the results of each control group met the requirements. The results show that the membrane filtration method is suitable for the microbial limit test of ‘compound alum powder’. Conclusion: this microbial limit test method control and ensure the quality of drug production by solving the problem of interference of antimicrobial components in drugs. It can eliminate the bacteriostasis of boric acid, phenol and alum.

Assessment of heavy metals in Hibiscus sabdariffa calyces and Moringa oleifera leaves collected from different areas in Tanzania

Medicinal plants are known in prevention and curing of diseases. Contamination of medicinal plants by heavy metals is one of the factors affecting quality of medicinal products from medicinal plants. Heavy metals may enter the edible and medicinal plants through contaminated environment such as water bodies, air or soil. Hibiscus sabdariffa calyces and Moringa oleifera leaves are used in Tanzania as nutritional and disease-remedial herbal drinks. This study assessed heavy metal contamination of Hibiscus sabdariffa calyces and Moringa oleifera leaves collected from Dodoma region (Vikonje, Msanga, Nzuguni A and Nzuguni B village), Pwani region (Kongowe and Chalinze village) and Shinyanga region (Mwime village). Lead, arsenic, chromium, cadmium and mercury were analyzed by Atomic Absorption Spectrometry. Microsoft excel 2010 software were used to analyze the means of heavy metal concentrations. Levels of chromium in the calyces and leaves of H. sabdariffa and M. oleifera ranged between 0.029-0.221 ppm and 0.019-0.088 ppm respectively while Arsenic was 0.096-0.204 ppm and 0.096-0.219 ppm, respectively. Mercury and Lead were found only in leaves of M. oleifera, mercury was between 0.017 ppm and 0.042 ppm and lead was 0.056 ppm. Cadmium was not detected in all plant materials. The concentrations of heavy metals in the selected samples were statistically significant at (P˂0.05). M. oleifera leaves and H. sabdariffa calyces, collected from different regions, had the low levels of heavy metals than recommended limits provided by the Tanzania Medicine and Medical Devices Authority (TMDA) and WHO.