RUS

About company[ 1.2 ]Manufacturing

Information on the enterprise

Highly-qualified managers, experts and operating personnel form the staff of the Kirov subsidiary.

Total number of employees constitutes 294 people including:
  • manufacturing – 127 employees
  • quality control division – 35 employees
  • quality assurance division – 6 employees
  • warehouse and distribution – 9 employees

         

    Manufacturing consists of:

    • Polifan section where Lignin substance is being produced;
    • Lignin-containing FPP products section where Lignin-based products are being manufactured;
    • FPP section for production of tablets, coated tablets, pills, HGC products;
    • Antibiotics production section (in a separate building) where penicillin antibiotics are being manufactured.

    Equipment which meets the requirements of GMP proper production rules is installed in the working area. Specified production facilities are indicated in Annex A.

    63 million of blisters were produced during 2013 (#10).

    Ventilation and conditioning systems, installed in each section, ensure air preparation for industrial premises and include:
  • Two-stage air filtration central conditioner (1st stage – G3-G4 filters; 2nd stage – F6-F9) maintaining climate parameters inside manufacturing buildings;
  • HEPA-filters of H11-H13 classes processing final air purification.
The air in the manufacturing buildings is diverted by the extraction system of ventilation via filters of G4 class.

The stages of water purification, performed by the system of receiving, storage and distribution of water (produced by the research and production company Mediana-Filter, Russia) are as follows:
  • Primary purification (removal of coarse suspended particles exceeding 500 µm);
  • Elimination of iron;
  • Dechlorination (via coal filter);
  • Softening (removal of hardness salts);
  • Transmission through reverse-osmotic membrane;
  • UV radiation processing.
PH-corrector is incorporated into the system for maintenance of water PH index within the prescribed limits.

Compressed air is used for:
  • Manufacturing equipment;
  • During the manufacturing process (injection of moisturizer, film coating, blister forming).

Preparation of compressed air includes:
  • Cooling (for moisture elimination);
  • Filtration (for removal of oil hard particles);
  • Dehumidification with the help of adsorption dehumidifier;
  • Final filtration (filter efficacy > 99,99998%);
  • Vapour generated of purified water (the temperature of vapour no less than 135 ⁰C) is used for thermal treatment of suspension during lignin hydrolised (Polifan) production.

Quality guarantee of each product is assured on each lifecycle stages:
  • Pharmaceutical development;
  • Technology transfer and transition of technology to the manufacturing;
  • Industrial production
  • Distribution.

General quality regulations of enterprise are defined and approved by the top-management of the company in the Quality Policy.

We admit that under present-day world conditions quality control alone FPP is not sufficient. Quality should be ‘implanted’ into the product, starting from the very early stages of its lifecycle, including pharmaceutical development, and we should make every possible effort to guarantee smooth-running operation of all the processes related to the product.

Company’s quality control division is the key unit which is directly involved in decision-making concerning modeling and optimization of business processes, assuring their continuous upgrading and improvement. 

Quality control division’s efforts are aimed at the following guarantees:
  • Manufacturing processes and equipment are validated with the guarantee of matching the highest criteria;
  • Quality control methods are validated in order to provide their reliability;
  • Personnel is highly qualified and takes regular training courses with further examination;
  • System of regular upgrading functions properly and is integrated into processes and procedures; also the company’s staff is encouraged to generate innovation ideas.

Company’s pharmaceutical quality system is a firm basis for confidence in the high quality, effectiveness and safety of the products. The company’s quality system is based on:
  • The current instruction on Good Manufacturing Practice (GMP);
  • ISO: 9000 standards.

Quality system of OJSC AVVA RUS is certificated in accordance with the following requirements:
  • National state standard ISO 9001-2011 (ISO 9001:2008). (Annex B);
  • National state standard P 52249-2009 (GMP) Good Manufacturing Practice for Medicinal Products.(Annex G).

The enterprise’s activity on production of medical drugs is performed under authority of License issued by the Ministry of Industry and Trade of the Russian Federation. (Annex B).

The enterprise’s activity on production of medical drugs is performed under the authority of License issued by the Industry and Trade Ministry of the Russian Federation (Annex B). We also continue to pay attention to our production quality after its delivery to consumers as well. Monitoring of the drugs quality is a crucial process in the quality management system effectuated by verifying the indicators of quality stability of the representative series of production during the shelf life and by effective functioning of the pharmacovigilance system.

We are open and are ready to respond immediately to any prospective complaints and quality complaints filed by our customers, from retail trade system, by state regulatory authorities. Either way, we investigate every single complaint, and consider it at the top management level because we believe there are no compromises in terms of quality and the quality of our production is a crucial priority for the company.

The Quality Policy

We produce medical drugs for the Russian consumers and also we export our products to a variety of countries around the world.
We are proud of our employees, their competence and qualification, they are confident that the enterprise shall excelon a multitude of different levels, not only in sales volume but also in level of service provided to the customers, in dynamism of innovations, price setting, quality of products and competence of the personnel.

AVVA RUS is striving to be a reliable supplier of effective, safe, high-quality medical drugs according to the market demands.
The company guarantees the quality of production at each stage and its responsible for the consumers and the staff. Due to the stable reputation in its home market it develops new markets for products.

We set ourselves goals concerning of quality to the satisfaction of all parties concerned:
  • Introduction and utilization of modern technology;
  • Modern equipment and production supporting systems;
  • Modern and relevant methods of products quality control;
  • Efficient use of intellectual capacity and knowledge management;
  • Maintenance of long lasting partner relationship and creation of new mutually beneficial relationships;
  • Possibility of professional and career growth for employees and proper compensation package.

Tasks solution is to be achieved through:
  • Maintenance and improvement of quality management system on the basis ISO 9001:2000, certification of production in accordance with Good Manufacturing Practice for Medicinal Products (GMP), integration of the Pharmaceutical Quality System on the basis of International Body on Harmonization (ICH Q8, ICH Q9 и ICH Q10);
  • Consideration and satisfaction of employees needs in competence upgrade and training;
  • Ongoing analysis and implementation of new methods of promotion regarding ethic principles;
  • Technical upgrade of full range of production process;
Continuous analysis and improvement of the enterprise functioning results due to competitors activity and consumers’ demand.

Top managers are aware of responsibility for comprehension of goals and tasks by every division of the company and agree to support all the measures aimed at implementation of the Quality Policy which they follow in partner relationship with consumers, suppliers and employees.

There is a policy of validation and qualification in the enterprise.:

The policy of validation comprises:
  • Analytical approaches;
  • Technological processes of manufacturing, prepacking and packing;
  • cleaning processes;

The policy of qualification comprises:
  • Systems of ventilation and conditioning of ‘the clean’ zones;
  • Systems of receiving and distribution of compressed air;
  • Systems of receiving, storage and distribution of purified water;
  • Industrial premises;
  • Technological equipment;
  • Laboratory equipment.

Control of primary goods, materials and finished products quality is performed by the quality control division which carries out the following tests:
  • Physical-chemical (including HPLC);
  • Microbiological.

A systematic monitoring of the products quality is being carried out and the results of each product monitoring are reported in the annual Surveys on Products Quality.

Systems functioning:
  • System of quality risk management via use of the analytical tool FMEA (analysis of characteristics and impact of defects);
  • System of change control.

An in-house research laboratory is available at the Kirov subsidiary of OJDCo AVVA RUS which performs development of medical substances and introduction of new medical substances and their forms.
Production of ointments, suppositories, syrups is in the process of development.