Binnopharm Group received 11 EAEU GMP certificates in 2023
30.01.2024
In 2023, Binnopharm Group's production plants obtained 11 compliance certificates according Eurasian Economic Union GMP requirements for pharmaceutical production.
PJSC Sintez located in Kurgan received 8 GMP certificates confirming compliance of active pharmaceutical substances and completed dosage forms manufacturing facilities, analytical, microbiological and pharmacological quality control laboratories with GMP requirements.
Another 3 GMP certificates were obtained by Binnopharm Group's production facilities in Obninsk and Zelenograd.
These GMP certification results were gained thanks to constant improvements of the pharmaceutical quality system (PQS) applied on the leading Binnopharm Group's production sites. To implement these improvements the company picked certain areas of PQS like quality control, deviations research, preparation of PQS corporate documentation. Significant part of the quality improvement process is developing of GMP culture and mentality among employees. According to recent requirements Binnopharm Group also invested into new high tech equipment, production sites renovation and modernization of engineering systems (water and air preparation and meteorological equipment).
For improvement process implementation few PQS areas were chosen, such as "quality control", "investigation of deviations", development of corporate documentation of the PQS. An important result of continuous improvement of the quality system at the production facilities was the development and maintenance of GMP-mentality among the company's personnel. In accordance with modern requirements, Binnopharm Group invested significant funds in the purchase of new process equipment, reconstruction and repair of production facilities, modernization of engineering systems (water treatment, air treatment and metrological equipment).
Naala Grivapsh, Corporate Quality Director of Binnopharm Group LLC: "Binnopharm Group effectively follows the strategy of international expansion. Our pharmaceuticals are sold in 13 countries around the world. We are currently working on market entry into China and South-East Asia. For this purpose, our production facilities need to comply with international and local norms and requirements for the production of medicines. The company's EAEU GMP certificates enable us to register medicines in the countries of the Eurasian Economic Union and the CIS, where we are already leaders in the export of Russian-made medicines".
PJSC Sintez located in Kurgan received 8 GMP certificates confirming compliance of active pharmaceutical substances and completed dosage forms manufacturing facilities, analytical, microbiological and pharmacological quality control laboratories with GMP requirements.
Another 3 GMP certificates were obtained by Binnopharm Group's production facilities in Obninsk and Zelenograd.
These GMP certification results were gained thanks to constant improvements of the pharmaceutical quality system (PQS) applied on the leading Binnopharm Group's production sites. To implement these improvements the company picked certain areas of PQS like quality control, deviations research, preparation of PQS corporate documentation. Significant part of the quality improvement process is developing of GMP culture and mentality among employees. According to recent requirements Binnopharm Group also invested into new high tech equipment, production sites renovation and modernization of engineering systems (water and air preparation and meteorological equipment).
For improvement process implementation few PQS areas were chosen, such as "quality control", "investigation of deviations", development of corporate documentation of the PQS. An important result of continuous improvement of the quality system at the production facilities was the development and maintenance of GMP-mentality among the company's personnel. In accordance with modern requirements, Binnopharm Group invested significant funds in the purchase of new process equipment, reconstruction and repair of production facilities, modernization of engineering systems (water treatment, air treatment and metrological equipment).
Naala Grivapsh, Corporate Quality Director of Binnopharm Group LLC: "Binnopharm Group effectively follows the strategy of international expansion. Our pharmaceuticals are sold in 13 countries around the world. We are currently working on market entry into China and South-East Asia. For this purpose, our production facilities need to comply with international and local norms and requirements for the production of medicines. The company's EAEU GMP certificates enable us to register medicines in the countries of the Eurasian Economic Union and the CIS, where we are already leaders in the export of Russian-made medicines".
