BIOTESTLAB Ltd. received the conclusion of the Certification Body for Products, Processes, and Services “Ukrainian Biological Certification Center”, on the compliance of the veterinary drug production sites with the requirements of Good Manufacturing Practice (GMP). The recertification audit of all production units was carried out in November 2020. Based on its results, the company received a corresponding certificate (No. GMP 10/18) valid for three years.
GMP is a mandatory certification standard for pharmaceutical industries in Europe and universally recognized in the world. Since 2018, GMP requirements in Ukraine have extended to the production of veterinary drugs both for sale in the domestic market and for export, as well as to veterinary drugs imported into Ukraine. Regulation is carried out in accordance with the "Rules of Good Manufacturing Practice for Veterinary Drugs" approved by the Order of the Ministry of Agrarian Policy and Food of Ukraine No. 606 dated November 10, 2017.
GMP requirements are harmonized with those in force in the European Union and are part of a system that ensures that veterinary drugs are produced and controlled in accordance with quality standards at all stages — from the moment raw materials and packaging materials arrive at the enterprise up to the shipment of finished products to the warehouse. At the same time, an important element of the system is the confirmation by an authorized person that each batch of veterinary drugs is manufactured and controlled in accordance with the requirements of the registration dossier.
Olena Saliy, Director of BIOTESTLAB Ltd.: “In 2015, our company received for the first time a GMP certificate for the production of vaccines for animals and poultry, antibiotics, antiparasitic agents, diagnostic veterinary drugs, as well as disinfectants and detergents for livestock premises.This was the result of many years of work on re-equipment of the main production and the start of new projects to ensure a consistently high quality of products. The company annually invests in R&D, production automation, and digitalization of processes. In addition, we use the possibilities of GMP for promotion in foreign markets — nowadays BIOTESTLAB products are exported to 22 countries".
The enterprise has designed clean rooms with a complex of locks and a special ventilation system with multi-stage purification of the supply air. Over the past three years, the new equipment for the production of immunobiologicals and a new line for washing vials have been installed, and we continue to modernize the chemical-pharmaceuticals production lines. The system for the preparation of water for injection has been modernized and equipped with modern equipment.
In 2018, based on the results of the inspection by the Ukrainian Biological Certification Center, BIOTESTLAB for the second time confirmed its compliance with GMP requirements and received a corresponding certificate.
Olena Saliy, Director of BIOTESTLAB Ltd.: “In addition to checking for compliance with GMP requirements, the company regularly undergoes external audits, including carried out by foreign partners, certification bodies, licensing and permitting authorities. To date, 22 external audits have been successfully completed. We have reached steady progress in the continuous improvement of quality processes in order to maintain the existing portfolio and new products development".
Recall: in 2020, BIOTESTLAB confirmed its compliance with the requirements of the international quality management standard ISO 9001:2015. The audit was carried out by the world leader in the field of certification DQS GmbH (Germany).