Quality Control Of Medicinal Products Research Articles

FEATURES OF THE FOREIGN STUDENTS TRAINING IN THE ELECTIVE DISCIPLINE "QUALITY SYSTEMS IN PHARMACY"

The pharmaceutical industry is rapidly developing and implementing new innovative approaches and legal regulation of the drugs quality management system, which includes a set of process methods and resources that are necessary for quality management. Therefore, the mastery by students of the specialty 226 "Pharmacy, Industrial Pharmacy" of the elective discipline "Quality Systems in Pharmacy" is an important issue of their professional training which will help them to master the methodology of quality management, normative-legislative and organizational-economic aspects of quality control of medicinal products at pharmaceutical enterprises. The elective discipline "Quality Systems in Pharmacy" is closely connected to some other disciplines, such as “Pharmacy and Industrial Technology of Drugs”, and “Technology of Cosmetic Drugs”. Training takes place according to the credit-module system in accordance with the basic requirements of the Bologna Convention.
 The main tasks of the elective discipline "Quality Systems in Pharmacy" are: providing the students with general knowledge about the quality indicators of medicines depending on the stage of their life cycle by fulfilling the requirements of good pharmaceutical practices and developing documentation in accordance with their requirements; formation of practical skills related to the rules and requirements for the creation, manufacture, research, distribution, sale, and storage of medicines in accordance with the requirements of good pharmaceutical practices operating in the European Union; improvement of the level of general and scientific development of students, formation of their outlook and perspective as modern qualified specialists in the field of pharmacy.
 The aim of the research is to study the peculiarities of the training of foreign students of the specialty 226 "Pharmacy, Industrial Pharmacy" in the Ivano-Frankivsk National Medical University (IFNMU) in the elective discipline "Quality Systems in Pharmacy". The subject of study of the discipline "Quality Systems in Pharmacy" is the methodology of pharmaceutical development, the components of the quality assurance system of medicines, including the requirements of the Guidelines of good practices in pharmacy for each stage of the life cycle of a medicinal product. The discipline is usually chosen by the well formed specialists.
 Teaching the elective discipline "Quality Systems in Pharmacy" at the specialty 226 "Pharmacy, Industrial Pharmacy" of IFNMU is necessary for students to thoroughly master the quality management system of medicines, it contributes to the optimization of the educational process and the improvement of the new principle of problem-oriented education of students and its control. This discipline orients students to the importance of the following issues: ensuring the quality of medicines at all stages of their life cycle; regulatory activities in the field of quality control of medicines; implementation of medicines; optimization and monitoring of pharmaceutical quality systems processes. This discipline forms the important competencies, knowledge, skills, abilities, and aspirations of students for self-development, while their teacher also develops and improves in the professional field together with students. Taking into account the trend of the European development of the pharmaceutical industry, the quality management system of medicines also should be harmonized with European standards.

Review of publications on drug-related problems investigations in osteoporosis patients

A chronic form of osteoporosis (OP) substantiates a long-term pharmacotherapy of patients, which increases the risk of adverse drug reactions (ADRs) during the therapy. The enhancement of requirements to the quality of safety monitoring carried out in the context of pharmacovigilance and the newly identified safety problems require an improvement of the system of quality control of medicinal products (MPs).The aim of the work was to review the application of a new promising method for monitoring the drug safety – the system of Drug-Related Problems (DRP) in the osteoporosis pharmacotherapy.Materials and methods. The following databases and search engines were used to retrieve scientific papers by Russian and foreign authors: PubMed, elibrary.ru, Google Scholar, CyberLeninka, Russian National Library. The information sources were searched using the following keywords and word combinations: “drug-related problems”, “drug safety”, “osteoporosis” (in Russian and English, respectively), as well as the corresponding MeSH terms.Results. The application of DRP system in the health care of different countries was reviewed, and the risk factors of the problems associated with the use of MPs, the appropriate interventions in case of the detection of high DRP values were investigated. The study of the problems associated with the use of MPs for the treatment of OP during the complex pharmacotherapy made it possible to determine the feasibility of using this method to improve the safety and effectiveness of this kind of treatment in patients.Conclusion. The analysis of emerging DRPs makes it possible to increase patients’ adherence to the treatment and stop the ADRs. This improves the quality of life of patients and increases the effectiveness of pharmacotherapy. The introduction of such a method of the drug safety research into the system of pharmacovigilance of the Russian Federation is an important step in the development of personalized medicine. A further study of problems associated with the use of drugs in OP patients will also help to reduce the risks arising during the combination pharmacotherapy.

Combination of a solid phase extraction and a two-dimensional LC-UV method for the analysis of vitamin D3 and its isomers in olive oil

The current HPLC methods for the quantification of vitamin D3 (VitD3) and its two isomers previtamin D3 (PreVitD3) and trans-vitamin D3 (trans-VitD3) in olive oil preparations present some limitations mainly due to peak overlapping of the oily matrix components with the compounds of interest. The use of two-dimensional liquid chromatography (2D-LC) with different retention mechanism can reach higher resolving power thus allowing the analysis of complex samples.The present paper proposes a new alternative method including a solid phase extraction sample preparation step and a two-dimensional liquid chromatographic analysis using routine instrumentation, fitting the needs of quality assurance and quality control laboratories of pharmaceutical companies. The extraction protocol was demonstrated to provide a clean-up of the sample and a quantitative recovery of the species of interest. The 2D method proved its suitability in the isolation of vitamins from oil components in the first dimension and the separation and quantification of the analytes in the second dimension thanks to the orthogonal selectivities of phenyl and porous graphitic carbon (PGC) stationary phases.The method was validated following ICH guidelines and possesses an adequate sensitivity to quantify the impurity trans-VitD3 in pharmaceuticals considering the limits imposed by regulatory agencies. The applicability of the phenyl x PGC 2D-LC-UV method to quality control of medicinal products based on VitD3 in olive oil was confirmed by the successful quantification of vitamins in olive oil formulations.

Determination of zinc content in insulin products by inductively coupled plasma mass spectrometry

Scientific relevance. Zinc content is a quality attribute of insulin products. The State Pharmacopoeia of the Russian Federation requires that it should be determined by flame atomic absorption spectrometry (FAAS). However, many pharmaceutical manufacturers currently prefer inductively coupled plasma mass spectrometry (ICP-MS), which is considered the most promising method for pharmaceutical and biomedical elemental analysis.Aim. The study aimed to develop and validate an ICP-MS-based analytical procedure for zinc content determination in insulin products.Materials and methods. The study focused on human insulin, insulin lispro, insulin aspart, and insulin glargine in the form of active substances, suspensions for subcutaneous injection, and solutions for injection from different manufacturers. Zinc content was determined on an Agilent 7900 ICP-MS; the analysis included 66Zn signal intensity registration.Results. The study compared the results of zinc content determination in test samples with either hydrochloric or nitric acid used as the solvent for sample preparation. The authors selected the experimental conditions to achieve relative standard deviations (RSDs) of not more than 2.5% for the measurements. The ICP-MSbased analytical procedure was validated for its specificity, linearity, accuracy, and precision in the range of 0.4–1.6 mg/L. The authors compared the measurements of zinc content made using FAAS and ICP-MS.Conclusions. The ICP-MS-based analytical procedure for zinc content determination in insulin products meets the validation criteria. This analytical procedure, as developed and validated, may be used in the quality control of medicinal products in the Russian healthcare system and at the batch release stage of pharmaceutical manufacturing.

Biological Reference Materials: Topical Issues of Development and Certification Procedure

Modern international requirements in the field of drug standardization determine the relevance of the development of reference materials (RMs) for quality control of medicinal products of various origins, including biological ones. Due to the complexity of monitoring the quality of biological products caused by the variability of the biological systems used, the development and certification of biological RMs is a priority. The purpose of this review is to describe the procedure for the development and certification of biological RMs, including consideration of the general principles for testing and calculating metrological characteristics based on an analysis of the domestic and foreign regulatory framework for RMs.

Development of a method for the quantitative determination of glibenclamide in tablets

Aim. To develop and validate a spectrophotometric technique for quantitative determination of glibenclamide in tablets by reaction with 2,3-dichloro-1,4-naphthoquinone. Materials and methods. In the study, the substance glibenclamide of pharmacopoeial purity was used, tablets – “Maninil” 5 mg and “Glibenclamid-Zdorovye” 5 mg, 2,3-dichloro-1,4-naphthoquinone of the “CFA” qualification was chosen as a reagent, as a solvent – dimethylformamide (DMF) “CFA”. The following analytical equipment was used for the research: spectrophotometer “Specord-200” (Analytic Jena AG, Germany), water bath “MEMMERT WNB7”, laboratory electronic scales RADWAG XA 210. 4Y, measuring laboratory vessels of class A. Results. A new, simple spectrophotometric method of quantitative determination of glibenclamide in tablets by reaction with 2,3-dichloro-1,4-naphthoquinone in DMF medium was developed. The absorption maximum was at 489–491 nm. The value of the detection limit is 10.9 μg/ml, which indicates sufficient sensitivity of the reaction. Subordination to the basic law of light absorption is within the limits of concentrations of 13.7–27.4 mg/100 ml. In the process of developing the methodology, the following validation characteristics were determined: specificity, linearity, precision, correctness, and robustness. Conclusions. The methodology for the quantitative determination of glibenclamide was developed and validated according to the requirements of the State Pharmacopoeia of Ukraine. It has been proven that the method is simple, accessible, and validated for such characteristics as linearity, convergence and robustness and can be used for application in laboratories for quality control of medicinal products.

Development and validation of a new spectrophotometric method for the determination of gabapentin in capsules

In Ukraine, there are about 100 thousand people with epilepsy. Gabapentin is an effective antiepileptic agent for oral use, presented in capsules of different dosages from different manufacturers. Therefore, the urgent task of pharmaceutical analysis today is the development of highly accurate, reliable, affordable and fast methods of quantitative determination. The aim of the work is to develop a spectrophotometric technique for the quantitative determination of gabapentin in capsules based on the reaction with diazole red 2J in compliance with the SPhU. Material and methods. As reagent and solvent, diazole red 2J of AR grade, acetone of AR grade and purified water was used. Analytical equipment: Specord 200 and Specord 250 Plus spectrophotometers, ABT-120-5DM and Radwag XA 210.4Y electronic scales, Elmasonic E 60H and Sonorex Digitec DT100H ultrasonic baths, measuring glassware of A class. Results. A simple, accurate and eco-friendly colourimetric method was developed for the quantification of gabapentin in capsules. The method was based on the reaction of gabapentin with diazole red 2J to give a coloured product having analytical maxima at 390 nm. Factors affecting colour development and stability were optimized and incorporated into the procedure. Regression analysis of Beer's plot showed a good correlation (not less than 0.999) in a concentration range of 2.10 – 3.64 mg/100 ml. The detection and quantification limits were 2.25 % and 6.19 %, respectively. The intra- and inter-laboratory precision demonstrates and reflects no interference by the capsule additives and confirms the reproducibility of the method in the selected concentration range. The prediction of the total uncertainty of the results of the developed method is calculated and displayed to assess the correctness of the reproduction of the method. Conclusions. It has been proven that the developed method meets the requirements of the State Pharmacopoeia of Ukraine and allows to perform the correct quality control of medicinal products.

ITS1 Barcode and Phytochemical Analysis by Gas Chromatography–Mass Spectrometry of Corynaea crassa Hook. f (Balanophoraceae) from Ecuador and Peru

The use of medicinal plants is the basis of traditional healthcare. Recently, the use of herbal medicine has been increasing among consumers due to availability, economy, and less side effect. For instance, the hemiparasite plant Corynaea crassa has medicinal properties and could be found in some regions of America, from Costa Rica to Bolivia. Phytochemical and genetic characterization of medicinal plants is needed for proper identification of metabolites responsible for medicinal properties and for genotyping, respectively. Moreover, characterization of medicinal plants through the use of DNA barcodes is an important tool for phylogenetic analysis and identification of species; furthermore, complemented with phytochemical analysis, both are useful for identification of plant species and quality control of medicinal products. The objective of this study was to analyze the species of C. crassa collected in Ecuador and Peru from the phylogenetic and phytochemical point of view. Polymerase chain reaction (PCR) was performed for amplification of the internal transcribed spacer 1 (ITS1) region after DNA extraction of samples of C. crassa. Blast analysis was performed in the GenBank database with the ITS1 sequences obtained from two accessions of C. crassa from Ecuador (GenBank accession numbers OM471920 and OM471919 for isolates CIBE-17 and CIBE-18, respectively) and three from Peru (GenBank accession numbers OM471921, OM471922, and OM471923 for isolates CIBE-13, CIBE-14, and CIBE-15, respectively). The accessions available in the GenBank were used for phylogenetic analysis. For the phytochemical analysis, hydroalcoholic extracts were obtained by maceration using 80% ethanol as solvent, followed by a derivatization process and analysis by gas chromatography-mass spectrometry. Based on the phylogenetic analysis of the C. crassa samples, the ITS1 sequence could be used to differentiate C. crassa of different locations. The samples of C. crassa from Ecuador and Peru are more similar between them than with other clades including Helosis spp. The phytochemical study revealed differences in the presence and relative abundance of some metabolites; mainly eugenol, 1,4-lactone arabinonic acid, dimethoxyrabelomycin and azelaic acid, which are reported for the first time for the species under study and the genus Corynaea. These results are the first findings on the combined analysis using genetic and phytochemical analysis for C. crassa, which could be used as a useful tool for quality control of the C. crassa species in medicinal products.

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.

HPLC Tests in Quality Control under the Market Surveillance Program for Medicinal Products Containing Amlodipine and Valsartan

Background: Quality is one of the three main characteristics of medicinal products. The quality assurance process is multi-stage: during the manufacturing, quality control is the commitment of the manufacturer, but after medicinal products become part of the distribution and pharmacy network, analytical quality control is carried out within the program for Market Surveillance. There are different approaches in conducting quality control of medicinal products under the Market Surveillance Program. Aim: The aim of the study is to compare the results obtained under two approaches: individual testing and testing by groups with the same active substance. Methods: In this study, comparative tests for assay and purity were carried out within two groups of medicinal products from the antihypertensive group containing Amlodipine besilate and Valsartan. Analyses were performed in accordance with the available pharmacopoeial monographs, as well as those from literature sources. Results: The results from the assay tests show a significant difference in the same product tested. Analytical methods for the determination of impurities also show different results when analyzing the same medicinal product. Conclusion: Considering the performed analytical tests, the obtained results can be used to make several conclusions and suggestions concerning the optimisation of the Annual Market Surveillance Program.

Recommendations on Describing the Requirements for Microbiological Quality and Sterility of Medicinal Products

The paper presents recommendations on describing analytical procedures for evaluation of medicinal products in terms of sterility and microbiological quality in accordance with the State Pharmacopoeia of the Russian Federation and the Pharmacopoeia of the EAEU. These quality attributes should be covered in Product specification files for any medicinal product. The paper describes specific considerations for preparation of the corresponding sections of the Russian or EAEU Product specification files. It is necessary to provide and justify quality requirements, refer to or describe the recommended analytical procedure and indicate differences, if any, from the standard one. Standardisation of the approach to microbiological quality control of medicinal products will allow analysts to accurately perform the tests, get reliable results and ensure the safety of medicinal products.

NMR as Used in the Russian and Foreign Pharmacopoeias for Quality Control of Medicinal Products

The ongoing development of the Pharmacopoeia of the Eurasian Economic Union and the current trend for harmonisation of the Russian Pharmacopoeia with the world leading pharmacopoeias suggest the necessity of studying how different pharmacopoeias use nuclear magnetic resonance (NMR) for quality control of medicinal products. The aim of the study was to compare the extent of medicine quality characteristics assessed by NMR in the Russian and foreign pharmacopoeias. The review summarises the experience of various national and world pharmacopoeias in using the NMR method for quality control of medicines and certification of pharmacopoeial reference materials. The comparative analysis covered the following quality parameters: active ingredient identification, determination of the composition of non-stoichiometric compounds, determination of the average polymer chain length in polymers and block copolymers, determination of the absolute content of the active ingredient, identification and quantification of impurities, polymorphism, and crystallinity. It was shown that the United States and Japanese Pharmacopoeias are leading the way in introducing the NMR method into pharmacopoeial analysis. There have been some positive trends in the introduction of the NMR method in the State Pharmacopoeia of the Russian Federation as well. It was concluded that changes are needed in the general chapters “Nuclear Magnetic Resonance Spectroscopy” and “Reference Standards” of the State Pharmacopoeia of the Russian Federation, 14th ed. in order to harmonise the texts with those of the Eurasian Pharmacopoeia and the European Pharmacopoeia and to allow for the possibility of direct identification of a substance by complex analysis of NMR spectral data, without comparing the test sample and the reference standard spectra. The NMR method should be included in the list of absolute methods used for determination of purity of primary chemical reference substances during certification.

Limitations of NIR Spectrometry as an Identification Test for Active Ingredients in Medicinal Products

Near-infrared spectrometry (NIRS) is a new pharmacopoeial method. It is widely used in the pharmaceutical industry for quality control of medicinal products at various production stages (control of raw materials and finished products), and for detection of substandard and counterfeit drugs.The aim of the study was to assess the feasibility of using NIRS as an identification test for active ingredients during pre-marketing quality control of medicinal products.Materials and methods: 327 drugs samples represented as solid and semisolid dosage forms were tested by NIRS following their examination by well-established pharmacopoeial Identification methods during pre-marketing laboratory evaluation. The NIR spectra of the test samples were compared with the spectral library classification models.Results: NIRS confirmed the identity of 3.1% of the tested medicinal products. It was demonstrated that library classification models could be used for identification of only those medicines that were produced by a specific manufacturer, i.e. for confirmation of medicine identity.Conclusions: the NIRS method is unpractical as an Identification test for active ingredients in medicinal products during the pre-marketing laboratory evaluation stage. The main limitations of NIRS are lack of complete sets of library classification models for all medicinal products available in the market and non-reproducibility of spectral library data obtained with a different instrument.

Methodological Approaches to Determination of Depressor Substances

In order to harmonise national and foreign requirements for quality control of medicinal products, a second variant of the test method, which complies with the requirements of the European Pharmacopoeia, was included into the general monograph OFS.1.2.4.0008.18 “Test for depressor substances”. The aim of the study was to compare the two variants of the in vivo test method that uses cats for determination of depressor substances in medicinal products and to develop recommendations for the use of these two variants of the test method. The comparative analysis of the two ways of determining impurities that lower blood pressure revealed different approaches to performing the test and to testing an animal's sensitivity to the reference solution (histamine dihydrochloride). It was demonstrated that different concentrations, volumes, and doses of medicinal products are used to assess the results of testing performed by variants 1 and 2 of the test method according to the pharmacopoeial requirements. Based on the established differences in the methodological approach to determination of depressor substances in medicinal products, the authors developed recommendations for each of the test variants. The inclusion of two variants of the test method in the general monograph provides an opportunity to evaluate the quality of medicinal products under the most appropriate conditions and, consequently, to improve the validity of test results.

Quantitative determination of trifuzol in the 2.5% injection solution by spectrophotometric method

The effectiveness of the treatment of common diseases of the respiratory system, hematopoietic system, digestive system of livestock and domestic animals with the help of existing drugs is not always sufficient, and there is an urgent need to expand the arsenal of domestic veterinary medicinal products that would exhibit antiviral, anti-inflammatory and low toxicity, prompted to search, create and improve existing veterinary medicines.
 A medicine in the form of a 2.5% injection solution containing, as an active substance, a 1,2,4-triazole derivative – piperidine 2-[5-(furan-2-yl)-4-phenyl-1,2,4-triazole-3-ylthio] acetate exhibits a fairly high level of anti-inflammatory, antiviral, and immunomodulating effects. The arsenal of domestic veterinary drugs with the above activity is currently limited.
 The analysis of veterinary medicinal products is the most important stage in the system for ensuring the quality control of medicinal products.
 During the entire storage period of the drug, various methods of identification and quantification of the active substances are needed. And despite the fact that spectrophotometry in the UV region is not very specific and selective, the expressness of these methods allows them to be widely used for routine quality control of drugs.
 Development and validation of a method for the quantitative determination of trifuzole in a 2.5% injection solution according to its own absorption.
 The study used a working standard sample of trifuzol 2.5% injection solution of trifuzol, as a solvent – purified water.
 Analytical equipment: Specord 200 spectrophotometer, electronic balance AVT-120-5DM.
 The aim of our work was the development and validation of a new, express method for the quantitative determination of trifuzol in the composition of a 2.5% injection solution in the UV region. The proposed method is based on measuring the optical density of an aqueous solution of a compound at 278 nm. The technique was successfully validated for such characteristics as linearity, precision, correctness, specificity and robustness, according to the requirements of HFCs. The analysis of the predicted total uncertainty of the analysis showed the reproduction of the method and the possibility of its application in other laboratories.
 The validation of the method for the quantitative determination of trifuzol in the composition of a 2.5% injection solution according to the requirements of HFCs was carried out. It is proved that according to such validation characteristics as linearity, specificity, precision, correctness and robustness, the technique is correct.

Some aspects of state quality control of medicinal products at regional level

The aim of this article is the analysis of normative legal acts that characterize changes in the legislation on the quality control of medicines, regulations and orders of the State Medical Service of Ukraine regarding the prohibition of the implementation of medical devices in the last 5 years and the substantiation of the conclusions aimed at further improving the quality assurance medical products (m/p). Results. It was revealed that of the 41 supplier countries in Ukraine, the predominant number of m/p that were banned from marketing, was found in 9 countries (67.98 %). The largest number of m/p that fell under the ban falls to Ukraine (32.25 %), India (15.98 %) and Germany (15.68 %), the lowest number of such m/p is represented by Belgium (5.03 %) Under the prohibition on the implementation of m/p by the release forms, the most commonly burned m/p in tablet form (43.63 %). Anti-hypertensive agents (18.23 %), antiseptic and disinfectants (15.63 %), as well as hormonal (15.63 %) were the leaders among the m/p for the pharmacological groups that most often fell under the prohibition on implementation. Conclusions. The analysis of the orders and instructions of the State Service of Ukraine to ban the sale of drugs in 2015-2018 indicates a significant decrease in their number in 2018, which indicates the improvement of the state drug quality control system. The largest number of drugs that were banned were found in Ukraine, India and Germany; predominant drugs in pill and liquid forms; Most often, antihypertensive, antiseptic, disinfecting and hormonal agents were banned. The introduction of a unified system for monitoring drug trafficking by labeling medicines with control identification marks based on 2-D coding will allow you to track the entire supply chain of medicines from the manufacturer to the end user and, accordingly, strengthen control over the quality of medicines, their production and import, which will counteract the ingress to Ukraine counterfeit or counterfeit drugs.

Culture Media in Pharmacopoeial Analysis: Use, Current Requirements, Standardisation

Culture media with predetermined specific characteristics play a key role in ensuring safety, quality and efficacy of medicinal products, especially biologicals. It is necessary to formulate clear criteria for culture media suitability, because they are used not only in manufacture, but also in quality control of medicinal products. The expansion of the range of complex high-technology medicinal products containing biologically derived substances as active ingredients, whose quality and properties are tested by biological methods, calls for more stringent requirements for the quality of culture media. The aim of the study was to analyse requirements for the culture media used in the production of medicinal products — in order to identify approaches to the development of a national standard. Currently, culture media are not included into the State Register of Medicinal Products, and there are no standards that could be used by manufacturers to confirm that a culture medium complies with specific safety, efficacy and quality requirements. The paper summarises the results of the analysis of the State Pharmacopoeia of the Russian Federation, 14th ed., and nine leading world pharmacopeias’ requirements for culture media used for various purposes (manufacture, auxiliary purposes, and quality control). Most countries have adopted requirements mainly for those culture media that are used in purity tests. The analysis revealed differences both in the lists of requirements (test strains, incubation and storage conditions, preparation for use, suitability assessment), and the approaches to the establishment and presentation of requirements. The paper discusses the main challenges and risks associated with the quality control of culture media in accordance with the requirements of the State Pharmacopoeia of the Russian Federation, 14th ed. It outlines current national and international ways of improving the quality of culture media used in the production of medicinal products, and substantiates the need to develop an appropriate national standard. The paper suggests approaches to the development and standardisation of requirements for the quality of various types of media used in the production and control of medicines. These approaches could be used in the preparation of the general chapter Culture media.

Modern science for better quality control of medicinal products “Towards global harmonization of 3Rs in biologicals”: The report of an EPAA workshop

This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations). To facilitate the global regulatory acceptance of non-animal methods for the potency testing of, e.g., human diphtheria and tetanus vaccines and veterinary swine erysipelas vaccines, international convergence on the scientific principles of the use of appropriately validated in vitro assays for replacing in vivo methods was identified as an overarching goal. The establishment of scientific requirements for new assays was recognized as a further means to unify regulatory approaches in different jurisdictions. It was recommended to include key regulators and manufacturers early in the corresponding discussions. Manufacturers and responsible expert groups, e.g. at the European Directorate for the Quality of Medicines and Health Care of the Council of Europe or the European Medicines Agency, were invited to consider leadership for international collaboration.

Practical implementation of the PIC/S principles in Ukraine after its accepting international requirements for quality control of medicinal products

Pharmaceutical Inspection Cooperation Scheme (PIC/S) is an international instrument of interaction between countries and regulatory authorities in the sphere of quality control of medicines (by national pharmaceutical inspectorates), which together provide an active and constructive cooperation in the field of good manufacturing practices (GMP), inspection and licensing. Aim. To develop a strategy, tactics and sequence of applying adaptation mechanisms to the pharmaceutical industry legislation of Ukraine according to EU and the PIC/S requirements. Results. In 2010, within Ukraine joining to the PIC/S the starting audit of researches on adaptation of medicinal products quality standards to the international requirements was carried out. In the period from March 22 to 26, 2010 the PIC/S audit team performed the final audit in order to check the readiness of Ukraine to join the PIC/S. On November 8,2010 a decision on Ukraine’s membership was made in Kuala Lumpur (Malaysia). Since January1, 2011 Ukraine has become the PIC/S member within the system of medicinal products circulation and quality control in accordance with GMP/GDP and EU Directive 2001/83/EC. During the period of Ukraine’s accession to the PIC/S system, accordingly, this Directive was improved. At the VIII National pharmaceutical Congress (Kharkiv, September 14-16, 2016) 26 additions to the decision of Congress were proposed, including questions related to the PIC/S and other legislative initiatives. Conclusions. Legislative documents of the system of medicines quality control and circulation inspection are the international requirements of the PIC/S. The principles, measures and requirements were developed, discussed and accepted that contributed to the accession of Ukraine to the PIC/S system in 2011.

The Role of Pharmaceutical Security in Realization of the Right to Health

Objectives: The articles analysis the role of convergence and harmonization of pharmaceutical regulation, as a basic component, ensuring pharmaceutical security and guarantying the realization of the right to health. Method: To achieve the main aim of the study national laws and documents of international organizations have been analyzed to identify main steps of human security concept formation and the role of access to healthcare in its realization. According to existing socioeconomic trends, main threats and challenges of pharmaceutical sector were identified showing the role of harmonization and convergence processes in its protection and realization of the right to health. Findings: An analysis of the processes taking place in different regions of the world, demonstrated the positive impact of regional integration to improve the health management system and the formation of common rules, regulating the drug market. Integration processes take into account regional specificities, providing point impact on the existing threats and challenges in the pharmaceutical sector, which allows neutralize differences in the capabilities of States to ensure the quality control of medicinal products within the same region. Focus on the convergence and harmonization of the legal framework will improve the drug regulatory system on a global level and ensure the quality of products used by patients, it is necessary to strengthen and provide numerous benefits for both regulators and the pharmaceutical industry and have a positive impact on the protection of public health. Improvements: The study result identifies main areas of harmonization and convergence of pharmaceutical regulations, which can be applied during regulation formation of any regional integrative organizations.