Manufacturing
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Highly-qualified managers, experts and operating personnel form the staff of the Kirov subsidiary.
Total number of employees constitutes 499 people including:
Total number of employees constitutes 499 people including:
226
manufacturing
67
quality control division
10
quality assurance division
18
warehouse and distribution
Production areas
workshop No. 1 and workshop No. 2
manufacture a wide range of drug products in the form of: uncoated tablets; coated tablets; pills; hard gelatin capsules; granules for oral solution; powder for oral suspension; suppositories; syrups and oral suspensions.
workshop No. 3
includes the Polyphan area where substance Lignin is manufactured and the area for the finished drug product manufacture on the basis of substance Lignin and herbal products.
workshop No. 4
carries out the manufacture of penicillin family antibiotics in the form of: uncoated tablets, coated tablets and powders for oral suspension.
workshop No. 5
carries out the manufacture of Pancreatin API, enteric-coated pellets to be used for the manufacture of Micrasim drug product.
in 2021
the enterprise is planning to put into operation the liquid dosage form workshop which will substantially increase the enterprise nomenclature and production capacity in terms of liquid forms.
in 2022
the enterprise is planning to put into operation a new solid dosage form workshop which will lead to a three-fold increase in the production capacity and create new jobs.
Cертификат
удостоверяющий соответствие создания, разработки,
производства и поставки медицинских средств на основе лигнина гидролизного
стандартам качества ISO 13485:2003
The manufacturing areas are fitted with the modern process equipment meeting the GMP requirements.
63
млн. блистеров №10 произведено за 2013
год
75
млн. блистеров №10 произведено за 2015
год
85,8
млн. блистеров №10 произведено за 2016
год
* Производственные мощности по единицам
оборудования предприятия указаны в Приложении А.
Modern pharmaceutical manufacture is impossible without organizing the ventilation and air conditioning systems in the manufacturing and storage premises to create and maintain the necessary climatic parameters.
The enterprise uses individual ventilation and air conditioning systems for each manufacturing and storage area. The ventilation and air conditioning systems perform the following tasks:
1. Purifying the incoming air from airborne particles using absolute filters which makes it possible to ensure the high-efficiency purification (HEPA).
2. Creating, maintaining and controlling microclimatic parameters in clean rooms (temperature, relative humidity, air exchange rate) which are the keys to ensuring the product quality and compliance with the applicable sanitary and labor protection standards.
3. Ensuring the necessary pressure differences between the manufacturing premises which provides for the absence of product contamination.
4. Ensuring environmental protection through the use of absolute filters in exhaust systems which makes it possible to comply with the established ecological norms and environmental protection standards.
The enterprise uses compressed air as:
energy carrier to ensure the power supply of process equipment;
working environment in the course of the technological process (injection of humidifier, film-coating, blister formation, etc.).
The enterprise’s compressed air preparation system includes:
preparation of compressed air using oil-free screw compressors;
pre-filtration (to retain 100 % of particles up to 1 µm and 99.9 % of particles up to 0.3 µm);
drying of compressed air using an adsorption dryer;
filtration (to retain dust, liquid and aerosol particles up to 0.01 µm);
filtration (to retain dust particles up to 1 µm and 99.9 % of dust particles up to 0.3 µm);
filtration (to retain 99.98 % of dust particles up to 0.01 µm);
use of receivers (accumulation of compressed air);
finishing filtration (filtration efficiency > 99.99998 % per 0.01 μm);
AVVA RUS JSC KB prepares purified water from potable water using a purified water preparation, storage and distribution system. The process includes the following stages:
pre-cleaning of coarse suspended particles;
deferrization;
dechlorination;
softening;
cleaning by reverse osmosis;
UV treatment;
collection and storage in a closed container.
Ensuring the 24 h water circulation and distribution by manufacturing areas.
24 h purified water quality monitoring in terms of chemical and microbiological parameters.
Quality policy
The quality of each of our products is ensured at each stage of the life cycle:
01
Pharmaceutical development
02
Technology transfer or technology transfer to manufacture
03
Commercial-scale manufacture
04
Distribution
The enterprise’s general quality intentions are included in the Quality Policy approved by the company’s top management.
We recognize that in the modern world carrying out the finished product quality control only is insufficient and that it is necessary to “embed” the quality by design of the product starting from the earliest stages of its life cycle including pharmaceutical development and to apply every possible effort to guarantee the uninterruptedness of all the product-related processes.
The company's Quality Service is a key unit that is directly involved in making decisions in the sphere of modeling and optimizing business processes to ensure their continuous development and improvement.
We recognize that in the modern world carrying out the finished product quality control only is insufficient and that it is necessary to “embed” the quality by design of the product starting from the earliest stages of its life cycle including pharmaceutical development and to apply every possible effort to guarantee the uninterruptedness of all the product-related processes.
The company's Quality Service is a key unit that is directly involved in making decisions in the sphere of modeling and optimizing business processes to ensure their continuous development and improvement.
The manufacturing block-related efforts of the Quality Service are aimed at guaranteeing that:
The manufacturing processes and equipment are validated to ensure compliance with the most rigorous criteria;
The quality control methods are validated to ensure their reliability;
The personnel are supremely qualified and undergo special training and regular knowledge assessment;
The continuous improvement system is duly operating and integrated into the processes and procedures, and the company personnel are motivated to generate innovations.
The company’s pharmaceutical quality system is a solid basis for ensuring the highest quality, efficacy and safety or company products.
The quality of the medicinal products manufactured by the enterprise is ensured through the use of the quality system operating at all stages of the drug product life cycle. The enterprise has implemented and maintains:
The Rules of Good Manufacturing Practice (approved by Order No. 916 of the Ministry of Industry and Trade of the Russian Federation of 14 June 2013), which is confirmed by Certificate No. GMP-0055-000493/20 of the manufacturer’s compliance with the Rules of Good Manufacturing Practice issued by the Ministry of Industry and Trade of the Russian Federation;
The Rules Governing Medicinal Products in the European Union. Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, which is confirmed by Certificates No. AVVA RUS19 2018/01 and №AVVA RUS18 2018/01 of the manufacturer’s compliance with the GMP Rules issued by the Ministry of Health of the Republic of Cyprus.
The enterprise carries out the medicinal product manufacturing activities based on License No. 00200-ЛС issued by the Ministry of Industry and Trade of the Russian Federation on 16 March 2020.
We do not stop paying attention to the quality of our products after their shipment to consumers – the drug product quality monitoring is an integral part of the pharmaceutical quality system implemented by way of carrying out the stability testing of drug product quality parameters throughout the product shelf lives and ensuring the efficient operation of the pharmacovigilance system. We are open and ready to immediately and efficiently respond to potential complaints and quality claims that may be received from the consumers of our products, pharmacy network or state regulatory body. Each complaint is subject to investigation, and the information about it is considered by the company’s top management, as we believe that there can be no compromise in the quality matters and there are no higher priorities for the company than the quality of our products.
We manufacture medicinal products not for Russia only, but also export our products to different countries of the world.
We are proud of the professionalism and modern level of training of our employees who are confident that the enterprise should meet the challenges related to dynamic innovation, pricing, product quality and personnel qualification not only in terms of sales but also in terms of the level of services provided to its customers. AVVA RUS strives to be a reliable supplier of efficient, safe and high-quality medicinal products in accordance with the market requirements.
The company ensures the product quality at each stage, bears responsibility before the consumers and its own personnel and develops new markets for products due to its strong image in the domestic market. To satisfy all the interested parties, we set ourselves the following quality tasks:
production of efficient and safe products that maintain the appropriate quality throughout their shelf lives;
development and introduction of innovative products into production;
availability of products to a wide range of consumers in the Russian Federation and in the near and far-abroad countries;
operation and continuous improvement of the pharmaceutical quality system to ensure the appropriate quality of the products released;
carrying out the manufacture using the high-tech equipment meeting the established GMP standards;
ensuring efficient process management in the quality sphere;
ensuring the systematic improvement of the personnelqualification level;
using high-quality source raw materials;
monitoring and implementation of a set of measures to reduce the negative impact of the manufacturing processes on the personnel health and environment.
The tasks will be resolved through:
Maintaining and improving the ISO 9001-based quality management system, certifying the entire manufacture for compliance with the Rules of Good Manufacturing Practice (GMP), creating the Pharmaceutical Quality System based on the principles of the International Council for Harmonisation (ICH Q8, ICH Q9 and ICH Q10);
Taking into account and satisfying the personnel need for improving competence and training;
Continuous analysis and implementation of new promotion methods taking into account the applicable ethical principles;
Technical upgrade to the full manufacturing process cycle;
Continuous analysis and improvement of the enterprise performance against the competitors and the requirements of consumers;
The enterprise’s top management is aware of its responsibility for ensuring the understanding of goals and objectives by all the company’s divisions and services and is committed to support the implementation of the Quality Policy which regulates its relationship with consumers, suppliers and employees.
The company has in place the operating validation policy and the qualification policy.
Validation is carried out in relation to:
test procedures;
technological processes of manufacture, filling and packaging; cleaning processes.
Qualification is carried out in relation to:
clean area ventilation and air conditioning systems;
compressed air preparation and distribution system;
purified water preparation, storage and distribution system;
manufacturing premises;
process equipment;
laboratory equipment.
The quality control of raw and other materials and finished products is carried out by the Quality Control which carries out the following tests:
The quality control of source raw materials and finished products is carried out using the following methods:
Physical analysis;
Chemical analysis;
Physico-chemical analysis;
Biochemical analysis;
Microbiological analysis.
The company carries out the systematic product quality monitoring the results of which are reflected in the annual
Product Quality Reviews prepared for each drug product name.
The enterprise has the following operating systems:
quality risk management system which uses the FMEA (failure mode and effect analysis) method;
change control system;
system for handling nonconformities, reviewing consumers’ complaints and claims, handling deviations;
personnel training system.
Photos of the enterprise
Research laboratory
The Kirov branch of AVVA RUS JSC has its own testing and technological laboratory engaged in developing the formulations for medicinal products and implementing new medicinal products and their dosage forms.
