BIOLEK PHARMA IS A MANUFACTURER OF IMMUNOBIOLOGICAL, PHARMACEUTICALS, MEDICAL DEVICES FOR IN-VITRO DIAGNOSTICS, HYGIENE AND PREVENTIVE PRODUCTS.

Today BIOLEC PHARMA is certified according to such standards as ISO 9001, ISO 13 485, which allows us to compete with modern companies. Every year we improve and do not yield to modern trends both in ensuring proper quality and in new approaches to the organization of production.

The result of our work is obtained GMR certificate, new equipped premises for sterile production, modern equipment, staff trained in all requirements of GMP, ISO 9001, ISO 13 485, modern laboratories, new unparalleled drugs, pharmaceutical quality system, which is fully implemented and functioning at the company, implementation of food safety requirements – HACCP system, external audits of companies providing services.

Every year we set ourselves new tasks – expansion, modernization and payback of production, obtaining new international certificates, automation of production, new markets for products, attracting new suppliers and manufacturers of raw materials and materials to produce quality products, attracting external experts to share experience in consulting services, regular external and internal training of employees, development of new methods of quality control, expanding the range of products, improving the efficiency of the company’s operations, and improving the quality of its products.

PRODUCTION

BIOLEK PHARMA is the only manufacturer in Ukraine of such preparations as: “Ekteritsid®”, ‘Antirabic (horse) immunoglobulin’, ‘Enkad-Biolek’, ‘BIOLEK Tuberculin PPD-L’, ‘Lipin-Biolek®’, ‘Liolov-Bio®’, ‘Lipoflavone’, ‘Tropisetron’, as well as vaccines and diagnostic preparations.

BIOLEC PHARMA products are represented in the pharmaceutical markets of the following countries: Azerbaijan, Kazakhstan, Turkmenistan, Uzbekistan, Armenia, Kyrgyzstan, Georgia.

QUALITY MANAGEMENT

BIOLEC PHARMA has established, implemented, operated and continuously improved a Pharmaceutical Quality System (PQS) in accordance with current regulatory requirements and Good Manufacturing Practice (GMP) standards. The system aims to ensure and continuously maintain an appropriate level of product quality and compliance with current good practices in the following systems: quality assurance, logistics, manufacturing, packaging and labeling, facilities and equipment, quality control, development and research, and business process improvement of the company.

The company is guided by the Quality Policy in relations with customers and suppliers, supports all measures aimed at the realization of this policy.

The quality system is certified in accordance with the requirements of international standards ISO 9001, ISO 13485.

Laboratories of the Quality Control Department are certified by the State Service of Medicinal Products of the Ministry of Health of Ukraine for the right to carry out quality and safety control of medicines

OUR OBJECTIVES

In the field of quality assurance BIOLEC PHARMA sets the following objectives:

• Ensuring compliance of product development, manufacturing and distribution processes with the requirements of national and international standards in the field of GxP, ISO 9001, ISO 13485, ISO 22000.
• Continuous evaluation, improvement and performance enhancement of the pharmaceutical quality system and product safety management system.
• Application of the PDCA (Plan-Do-Check-Act) cycle to all processes.
• Planned reconstruction of production sites through modernization and technical re-equipment in accordance with the requirements of national and international standards.
• Effective risk management based on scientific knowledge and acquired experience to protect the end user.

• Continuous monitoring of safety profile, assessment of benefit/risk compliance of medicines, effective risk management in the pharmacovigilance system.

• Continuous improvement of the quality and safety of manufactured products.

• Comprehensive personnel training and involvement of the company’s employees in quality and safety management processes at all stages of the product life cycle.

• Satisfaction of consumer demands in full.

• Expansion of the product range and development of new markets.

• Establishment of partnership relations with suppliers and consumers on the basis of mutual understanding and cooperation.

• Rational use of raw materials and supplies by reducing costs and improving technologies.