Information
Where to buy
WHOLESALE
Distributor PHARMBIOPROM
Ryabinovaya str. 43 p 1 Moscow 121471 Russia
Phone: +7 (499) 737-88-82
Phone: +7 (905) 537-62-02
info@farmbioprom.ru
Distributor PHARMBIOPROM
Ryabinovaya str. 43 p 1 Moscow 121471 Russia
Phone: +7 (499) 737-88-82
Phone: +7 (905) 537-62-02
info@farmbioprom.ru
Informational report
View the document drug Gabriglobin@ - IgG-packaging 25 ml., 50 ml. produced by LLC "Immuno-Hem" from 2008 to the present. In addition, in 2020, the volume of production is planned to be 25% higher compared to 2019. For reference, we inform you that from 29.11.2019 on the territory of the Russian Federation there is a new procedure for entering into civil circulation of medicines for medical use. So, immunobiological medicinal products which include, including Gabriglobine@-IgG are entering into civil circulation after the test for all quality indicators in the Federal Ministry of health of Russia, or of the Committee for Social Policy and Healthcare of the Federation Council of Russia, the corresponding conclusion and the issuance of its authorization .
For questions about purchasing the drug, please contact the Distributor of LLC "Immuno-Hem" - LLC " FARMBIOPROM"
For questions about purchasing the drug, please contact the Distributor of LLC "Immuno-Hem" - LLC " FARMBIOPROM"
Quality policy of the company "Immuno-Gem"
The company "Immuno-Hem" has been manufacturing medicines since 1999. The main activity of LLC "Immuno-Hem" is the production and development of medicines from human blood plasma and products of its processing.
Our mission is to provide patients with affordable and high-quality domestic medicines with guaranteed effectiveness and safety.
The goal of our work is the production and release to the market of domestic medicines, the quality of which is guaranteed and ensured by embedding a quality management system in all stages of the product life cycle and compliance with the Rules of good manufacturing practice.
To achieve these goals, the company implements and continuously improves the pharmaceutical quality system (FQS), focusing on the following principles:
We are focused on the consumer. Striving to meet their needs and expectations and ensuring their safety is the priority basis of our activities.
Leadership of the manager ensures a common understanding and implementation of the tasks set by the team. Management is responsible for the implementation and proper functioning of the FQS at enterprises in order to guarantee the release of medicines that meet their intended purpose, the requirements of the registration dossier and to eliminate the risk associated with unsatisfactory quality, safety and effectiveness.
The company's staff is involved in solving the tasks set. The staff has the necessary qualifications, knowledge and experience. Continuous training and improvement of personnel is carried out. Each employee is responsible for the duties assigned to them.
A process approach to managing the Federal grid company and the enterprise as a whole is being developed and implemented. The company's activities are considered as a system of interrelated processes, which provides greater efficiency and effectiveness in achieving the organization's goals.
We strive to continuously improve the company's performance, based on the analysis of the results achieved, focusing on advanced technologies and achievements, equipping production with new high-tech equipment.
In order to detect or prevent undesirable events and errors in a timely manner, we use risk analysis and nonconformity analysis, based on which we plan and implement corrective and preventive actions. We evaluate and analyze the impact of all corrective actions and changes on the product and the system as a whole.
We build relationships with contractors (suppliers of goods and services and distributors) on a mutually beneficial basis. We work only with approved contractors and try to ensure that our partners understand their role in ensuring the quality of our products.
The key to implementing the quality policy is:
Leadership of the management and attitude to the staff as one of the main values of the organization, their involvement in achieving the goals set.
Organization of production and quality control in accordance with the principles of GMP, continuous analysis and improvement of the FQS.
A systematic approach aimed at defining areas of responsibility and coordination of actions of all services and divisions. Implementation of an automated document management system aimed at improving internal interaction.
Management takes responsibility for implementing the quality Policy, including allocating the necessary resources and ensuring that it is understood by all employees of the company.
General Director of "Immuno-Gem" A. V. Kovaleva
Our mission is to provide patients with affordable and high-quality domestic medicines with guaranteed effectiveness and safety.
The goal of our work is the production and release to the market of domestic medicines, the quality of which is guaranteed and ensured by embedding a quality management system in all stages of the product life cycle and compliance with the Rules of good manufacturing practice.
To achieve these goals, the company implements and continuously improves the pharmaceutical quality system (FQS), focusing on the following principles:
We are focused on the consumer. Striving to meet their needs and expectations and ensuring their safety is the priority basis of our activities.
Leadership of the manager ensures a common understanding and implementation of the tasks set by the team. Management is responsible for the implementation and proper functioning of the FQS at enterprises in order to guarantee the release of medicines that meet their intended purpose, the requirements of the registration dossier and to eliminate the risk associated with unsatisfactory quality, safety and effectiveness.
The company's staff is involved in solving the tasks set. The staff has the necessary qualifications, knowledge and experience. Continuous training and improvement of personnel is carried out. Each employee is responsible for the duties assigned to them.
A process approach to managing the Federal grid company and the enterprise as a whole is being developed and implemented. The company's activities are considered as a system of interrelated processes, which provides greater efficiency and effectiveness in achieving the organization's goals.
We strive to continuously improve the company's performance, based on the analysis of the results achieved, focusing on advanced technologies and achievements, equipping production with new high-tech equipment.
In order to detect or prevent undesirable events and errors in a timely manner, we use risk analysis and nonconformity analysis, based on which we plan and implement corrective and preventive actions. We evaluate and analyze the impact of all corrective actions and changes on the product and the system as a whole.
We build relationships with contractors (suppliers of goods and services and distributors) on a mutually beneficial basis. We work only with approved contractors and try to ensure that our partners understand their role in ensuring the quality of our products.
The key to implementing the quality policy is:
Leadership of the management and attitude to the staff as one of the main values of the organization, their involvement in achieving the goals set.
Organization of production and quality control in accordance with the principles of GMP, continuous analysis and improvement of the FQS.
A systematic approach aimed at defining areas of responsibility and coordination of actions of all services and divisions. Implementation of an automated document management system aimed at improving internal interaction.
Management takes responsibility for implementing the quality Policy, including allocating the necessary resources and ensuring that it is understood by all employees of the company.
General Director of "Immuno-Gem" A. V. Kovaleva
