«Borisov Plant of Medical Preparations» OJSC is primarily concerned about the quality assurance and quality control of the manufactured medical preparations. Manufacturing facilities and conditions for production of medical preparations comply with the requirements of Good Manufacturing Practice (GMP). The company has thorough and ongoing assessment of the effectiveness of the current pharmaceutical quality system , which includes:
- quality management system;
- good manufacturing practice (GMP);
- quality control;
- quality-related risk management;
- regular and periodic assessment of the product quality.
Quality assurance and quality control of the products are performed at all manufacturing stages by a specialized quality service, which includes:
- Quality Assurance Department;
- Quality Control Department, consisting of a control group, as well as analytical and microbiological laboratories.
The company laboratories have been accredited within the accreditation system of the Republic of Belarus and have been granted the right to use the accreditation mark, as well as heve been provided with technical regulatory and legal acts, organizational and methodological documentation, testing procedures and modern highly selective and highly sensitive equipment. This fact ensures a high level of testing, from input control of raw materials and packaging materials to control of intermediate and finished products for the compliance with specifications, as well as microbiological monitoring of the manufacturing process.
«Borisov Plant of Medical Preparations» OJSC is aware of its responsibility to consumers for safety and efficiency of the
medical preparations. Quality of our products contributes to consumers’ health and is the guarantee of the future of our Company. «Borisov Plant of Medical Preparations» OJSC was awarded the Prize of the Government of the Republic of Belarus for quality of its products.
The pharmacovigilance system was introduced and operates at «Borisov Plant of Medical Preparations» OJSC in accordance with the international standards and law requirements towards medicinal products of the Republic of Belarus. Pharmacovigilance is the activity aimed at identification, evaluation, understanding and prevention of adverse consequences of the use of medical products. The main objective of the pharmacovigilance system is to control the safety of preparations, timely identify all changes in the evaluation of the medical preparations according to benefit-risk ratio, develop and implement measures to ensure safety of the use of medical preparations when the risk exceeds the benefit. The Company has been continuously getting feedback and collecting information regarding safety of the manufactured medical preparations. Collection, evaluation and reaction to all reports of adverse reactions related to the use of medical preparations, manufactured by «Borisov Plant of Medical Preparations» OJSC, are performed at the company on the regular basis.
Contacts of the pharmacovigilance service of «Borisov Plant of Medical Preparations» OJSC: