The Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines (Pharmacopoeial Center) is the leading scientific self-funded institution for standardization and quality control of medicines in Ukraine. The enterprise conducts systematic scientific research of both fundamental and applied nature. The quality standards developed by the Pharmacopoeial Center make a significant contribution to the development of the pharmaceutical industry in Ukraine and promote the establishment of our country as a leader in this field.
Brief Historical Reference
The Pharmacopoeial Center was founded as state property according to the order of the Ministry of Health of Ukraine No. 50 of March 19, 1992, and the resolution of the Cabinet of Ministers of Ukraine No. 663 of August 20, 1993 (original name ― Pharmacopoeial Committee). In accordance with the order of the State Department for Quality Control, Safety and Production of Medicines and Medical Devices No. 63 of November 28, 2000, the Pharmacopoeial Committee was renamed to the State Enterprise “Scientific-Expert Pharmacopoeial Center”, and in accordance with the order of the State Inspection for Quality Control of Medicines No. 07 of November 12, 2008, it was renamed to the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, SE.
Since 2014, in accordance with the Resolution of the Cabinet of Ministers of Ukraine dated September 10, 2014, No. 442, the enterprise has been under the management of the State Service of Ukraine on Medicines and Drugs Control (hereinafter ― State Service of Medicines).
Since 2022, the Pharmacopoeial Center has been a part of the collective members of the Technical Committee on Standardization TC 122 “Analysis of Gases, Liquids, and Solids” (order dated July 7, 2022, No. 124 issued by the National Standardization Body, State Enterprise “Ukrainian Scientific Research and Training Center for Problems of Standardization, Certification and Quality”.
The Pharmacopoeial Center has a well-developed organization, which includes: the Department of the State Pharmacopoeia of Ukraine, the Department of Validation and Reference Standards, the Laboratory of Pharmacopoeial Analysis, the Department of Experimental Support for the Development of Monographs on Herbal Drugs, the Department of Instrumental Methods of Analysis, the Department of General Pharmacology, as well as supporting economic and financial structures.
As of November 1, 2023, the Pharmacopoeial Center has 77 employees, of whom 29 hold scientific positions. Five colleagues have a Doctor of Sciences degree, and eleven colleagues hold a PhD degree, of which 1 is a professor, 7 are senior research associates, and 1 is a senior researcher.
The mission of the Pharmacopeia Center is aimed at meeting the needs of society in effective, safe, and high-quality medicinal products. It involves facilitating the establishment of European and other modern international standards of quality for medicinal products in Ukraine and integrating into the global pharmaceutical market.
Our Quality Priorities
- Maintain the operations of the enterprise at a high organizational and technical level.
- Make decisions based on facts and scientifically grounded judgments.
- Adhere to the rules of good professional practice, ensuring a high level of quality in measurements and obtaining reliable test results.
- Ensure the competitiveness of the company's services.
- Create favourable conditions for the professional development of the enterprise's employees.
- Maintain a high professional image and authority of the company as a leader in the industry without harming its reputation and that of the customer.
The Quality Management System of the Ukrainian Scientific Pharmacopoeia Center for Quality of Medicines in providing services for the certification of pharmacopoeial reference standards of the State Pharmacopoeia of Ukraine, development of the State Pharmacopoeia of Ukraine, and laboratory analysis of the quality of medicinal products and excipients is certified for compliance with the requirements of ISO 9001:2015, IDT.
Main Tasks and Areas of Work
- Development, maintenance, and publication of the State Pharmacopoeia of Ukraine.
- Development and maintenance of the National System of Pharmacopoeial Reference Standards.
- Quality control of medicinal products as assigned by the State Service of Medicines.
- Organization and implementation of the Proficiency Testing Program for Quality Control Laboratories of Medicinal Products.
- International cooperation.
- Prospective standardization.
Additionally, the Pharmacopoeia Center publishes a peer-reviewed scientific and practical journal Farmacom, which serves as an information forum for the publication of the State Pharmacopoeia of Ukraine and the dissemination of knowledge in the field of pharmaceutical sciences.
State Pharmacopoeia of Ukraine (SPhU)
The Ukrainian Scientific Pharmacopoeia Center for Quality of Medicines is the only institution authorized to develop, maintain, publish, and sell the State Pharmacopoeia of Ukraine (SPhU). The SPhU is a legal document that contains binding requirements for the quality of medicinal products manufactured, stored, controlled, and used in Ukraine. The SPhU is approved by the Minister of Health of Ukraine.
In 1998, Ukraine became an observer, and since 2013 it has been a member of the European Pharmacopoeia (Ph. Eur.). The SPhU publishes texts from the Ph. Eur. translated into Ukrainian, supplemented with national texts developed to address the needs of the local pharmaceutical sector. The first edition of the SPhU was published in 2001, and in 2004, 2008, 2009, and 2011, four Supplements to it were issued (SPU 1.1 – SPU 1.4). In 2014-2015, three main volumes of the SPhU 2nd edition were released, and in 2016, 2018, 2020, 2021, and 2023, six Supplements to it were issued (SPhU 2.1 – SPhU 2.6).
The development, maintenance, and publication of the SPhU is carried out by the Pharmacopoeia Center at its own expense.
The SPhU is the first national Pharmacopoeia among the post-Soviet countries.
Reference Standards of the State Pharmacopoeia of Ukraine (SPhU RSs)
Quality control of medicinal products is impossible without pharmacopoeial reference standards (RSs). Ukraine is the only post-Soviet country that has a national system of pharmacopoeial RSs. The Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines is the only institution authorized to establish, maintain, and issue the SPhU RSs. The SPhU RSs have international recognition.
The National SPhU RS system established by the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines is unique in the world. Currently, the nomenclature of SPhU RSs comprises about 1000 items and includes RSs of synthetic and natural origin for identification, assay, and impurity control. It largely meets the needs of domestic enterprises, allowing them to refrain from importing RSs and save considerable foreign currency funds. The SPhU RSs are also in demand abroad, with steadily increasing interest.
Quality Control of Medicines
The Laboratory of Pharmacopoeial Analysis of the Pharmacopoeia Center is the first accredited laboratory in Ukraine in the system of state quality control of medicinal products (since 1992). It has a full cycle of necessary pharmacopoeial methods and conducts state control and arbitral analysis of medicinal products at the request of the State Service of Medicines and the appeals of business entities.
The laboratory is a leader in Ukraine in developing new and complex pharmacopoeial procedures. The vast majority of chromatographic techniques in the 1990s were developed at the Laboratory of Pharmacopoeial Analysis. The laboratory was the first in Ukraine to start developing methods and conducting analyses of finished medicinal products and pharmaceutical substances for the content of bacterial endotoxins and depressor (histamine-like) substances. Currently, it is the only laboratory in Ukraine that performs the evaluation of the reactogenic properties of pharmaceutical preparations and substances in vivo based on the Antigenicity indicator and tests for the presence of dangerous depressor impurities of histamine-like nature in the Depressor substances test. Additionally, the laboratory is a leader in Ukraine in issues of molecular mass distribution of high molecular weight preparations, identification, and quantitative determination of the activity of low molecular weight and standard unfractionated heparins, etc.
Proficiency Testing Program for Quality Control Laboratories of Medicinal Products
Ukraine is the only post-Soviet country to have its own Proficiency Testing Program (PTP) for Quality Control Laboratories of Medicinal Products within the State Service of Medicines system, which allows for the assessment and control of an appropriate level of performance in quality control laboratories of medicinal products. The PTP is developed and conducted by the Ukrainian Scientific Pharmacopoeia Center for Quality of Medicines. To date, 18 PTP rounds have been organized, conducted, and discussed at final scientific and methodological seminars, with about 60 laboratories from Ukraine and neighbouring countries participating in each round.
PTP provides not only mandatory independent external testing of laboratory activities but also feedback to the SPhU users, which allows for its improvement. Such feedback with the pharmacopoeia is unique.
The main goal of the international cooperation carried out by the Ukrainian Scientific Pharmacopoeia Center for Quality of Medicines is to introduce modern European quality standards for medicinal products and to integrate Ukraine into the global pharmacopoeial process aimed at ensuring a high level of health protection for the population and increasing the international community's trust in the Ukrainian healthcare system and domestic medicinal products.
In 1998, Ukraine obtained observer status, and since 2013, it has been a full (38th) member of the European Pharmacopoeia (Ph. Eur.). According to the Decree of the President of Ukraine, employees of the Ukrainian Scientific Pharmacopoeia Center for Quality of Medicines are members of the Ukrainian delegation to the European Pharmacopoeia Commission.
In 2010, the Pharmacopeia Center became a voting member of the US Pharmacopoeia Convention and first signed an Agreement regarding the possibility of using the texts of the United States Pharmacopeia (USP-NF) in the SPhU for a term of 10 years. In 2021, an Agreement was concluded that grants the Pharmacopoeia Center the right to use and adapt the texts of the 2019 USP42-NF37 in the SPhU.
In 2013, the Ukrainian Scientific Pharmacopoeia Center for Quality of Medicines first signed, and in 2017 and 2023, extended the Memorandum of Understanding with the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom regarding the possibility of using the texts of the British Pharmacopoeia (BP) in the SPhU for a term of 5 years each.
In 2023, the Pharmacopoeia Center secured permission to use the texts of the German Pharmacopoeia (DAB 2023) and the Homeopathic Pharmacopoeia (GHP 2022) in the SPhU.
Agreements with the Pharmacopoeias of the United States, the United Kingdom, and Germany are crucial for the development of SPhU monographs on finished medicinal products, as they are almost absent in the European Pharmacopoeia.
The Pharmacopoeia Center has established connections with pharmacopoeias and international standardization organizations of many countries around the world. In particular, our employees are experts in working/expert groups of the European Pharmacopoeia, the International Pharmacopoeia, and the European Association for Metrology in Analytical Chemistry (EURACHEM). Moreover, employees of the Pharmacopoeial Center are members of key intergovernmental committees of the Council of Europe that deal with ensuring the safety, responsible manufacturing, and availability of medicines across Europe.
Prospective standardization is the scientific support for all areas of work of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines.
The Pharmacopoeial Center conducts systematic scientific research of both fundamental and applied nature in the following main areas:
- Theoretical and applied issues of thin-layer, liquid, and gas chromatography;
- Multicomponent spectrophotometry;
- Quantitative consideration of a priori information;
- Certification of pharmacopoeial reference standards;
- Validation of analytical procedures and technological processes;
- Proficiency testing of control laboratories;
- Metrological aspects of ensuring the quality of analysis results;
- General and specific issues of pharmaceutical analysis;
- Standardization of Dissolution test procedures and comparison of dissolution profiles;
- Standardization and quality control of herbal drugs and herbal drug preparations;
- Microbiological purity of medicinal products;
- Testing for bacterial endotoxins.
Most scientific achievements in the pharmaceutical field in Ukraine over the last 30 years have been obtained with the contributions of employees of the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines.