Quality Control Of Medicinal Products Research Articles

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.

Pharmacognostic Evaluation of Spigelia anthelmia Linn (Loganiaceae)

Aims: To establish the pharmacognostic standard for S. anthelmia with a view to assisting in the standardization and quality control of medicinal products from the plant. Study Design: Pharmacognostic assessment of Spigelia anthelmia . Place and Duration of Study: Department of Pharmacognosy laboratory, University of Ibadan, Nigeria. Between 2013 and 2014. Methodology: Chemo microscopic evaluation and determination of physicochemical prop erties (moisture content, ash values, extractive values) of the powdered whole plant as well as studies of the macroscopic and anatomical sections of the leaf were carried out using standard methods. Results: Evaluation of the macro and microscopic charact ers showed that the stem is greyish green with smooth bark, the leaves are opposite, simple and entire. The leaf epidermis is straight with numerous starch grains and calcium oxalate crystals. The stomata are anomocytic while the trichome is uniserate. The physichochemical parameters for the whole plant are: Moisture content 11.0 ± 0.05 %, total ash 14.67 ± 0.05 %, acid insoluble ash 3.33 ± 0.01%, sulphated ash 11.0 ± 0.05 %, alcohol soluble extractive 0.25 ± 0.06 % and water soluble extractive 0.69 ± 0.02 %. Conclusion: The results of this research provided information which can be included in official monograph of the plant for its proper identification. Original Research Article

Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre

The production of pharmaceuticals is one of the most highly regulated fields in terms of quality. The body of good manufacturing practice (GMP) represents the standard required by law; GMP embraces the guidelines that regulate all activities related to the production and quality control of medicinal products for human and veterinary use. This paper deals with the implementation of a quality management system (QMS) in compliance with GMP and ISO 9001 standards for the production and distribution of radiopharmaceuticals in a public research institute. The production of 2-[18F]fluoro-2-deoxy-d-glucose has been implemented according to GMP standards and has been licensed by the national Authority in 2007. In 2010, a project to orient the system’s GMP compliance to ISO 9001 standards has been approved. A QMS conforming to ISO 9001:2008 should be considered an important additional step in terms of quality, because ISO 9001 also takes into account economic and financial aspects, design and development aspects and introduces management review for measurement and analysis of the process with the aim of improving performances. The harmonization between GMP and ISO has been defined following the Pharmaceutical Quality System Q10 guideline developed by International Conference on Harmonization.

A Somatropin Counterfeit Challenging the European Pharmacopoeia Monograph

Samples of a substance purported to be somatropin were submitted to the European Department for the Quality of Medicines laboratory for investigation by the German Medicines Control Authorities. Complete characterization of the sample was performed by a combination of liquid chromatography-mass spectrometry and amino-terminal sequencing. These data demonstrated that the active ingredient was not somatropin but des-Phe1 -human somatropin. The batch of product did not comply with the specifications in the European Pharmacopoeia monograph on Somatropin for Injection (0952), and so could not be released on the European market. Analytical procedure is a field of rapidly evolving technology. Nevertheless, despite the introduction of highly sophisticated technology used in the develoment of medicinal products, this paper indicates that classical analytical procedures in combination with appropriate specifications are still valuable tools for monitoring the quality control of medicinal products.

A new detection method of mistletoe lectin I by surface plasmon resonance

Mistletoe lectin I (ML-I) is considered as the main effective substance in the extract of mistletoe and is currently widely applied in cancer therapy. The Plasmonic® surface plasmon resonance (SPR) device was used to establish an innovative, simple and rapid assay for detection of ML-I in buffer, serum and injection drugs. In the reported sandwich immunoassay, specific anti-ML-I A chain antibodies were used as capture and detection antibodies. Trials were undertaken to compare the influence of detection signals by using four different types of functionalised chips. It was found that alkylsilane-coated chip got the highest detection signal and showed the lowest unspecific binding of the detection antibody. Hence the assays were established on alkylsilane-coated chips in both buffer system and serum system. For the buffer system, it was measured as a detection range of 7.5–100μgmL−1 and lower limit of detection of 1.0μgmL−1. In the serum system, the linear standard calibration curve indicated that the detection limit of ML-I by SPR was 1.5μgmL−1. The method also was verified to quantify the contents of mistletoe extract in commercially available injection drugs. In this novel approach, no laborious sample preparation is required. And it is less time-consuming compared to other biotechniques normally used at present. The system can be utilised not only for exploring properties of ML-I in biological research but also for the quality control of medicinal products of mistletoe in the pharmaceutical industry.

The taste sensory evaluation of medicinal plants and Chinese medicines

The purpose of this study was to investigate the use of the artificial taste sensor in the evaluation of 11 medicinal plants and 10 Chinese medicines with bitter and/or astringent tastes, and to assess the possible application of the sensor in the evaluation of taste and quality control of medicinal products. Aqueous extracts of the six bitter medicinal plants could be classified into three types, and those of the five astringent medicinal plants into two types, on the basis of sensor output pattern profiles. These differences seem to derive from the different structures of the main components. In the principal component analysis of the taste sensor output of 10 Chinese medicines, a new measure developed, the ‘Euclidean distance’, defined as the distance between a control and the targeted substance on the principal component map. This measure offers a possibility for indicating the different tastes of Chinese medicines. Lastly, we confirmed that berberine adsorption on the surface of the artificial membrane of the taste sensor was of the Langmuir type. The berberine content in extracts of medicinal plants could be evaluated by the taste sensor, and it was shown to be possible to use the taste sensor for the quality control of medicinal plants.

Notes to applicants for marketing authorizations on the production and quality control of medicinal products derived by recombinant DNA technology

Notes to applicants for marketing authorizations on the production and quality control of medicinal products derived by recombinant DNA technology