International certificate GMP - guarantee of quality

Since the founding, "Vetsintez" LLC in its activity gives the priority to customer satisfaction. This principle became the starting point in the further development and improvement of the company. Already at very early stages of "Vetsintez" development, the company was consistently seeking for new customers and clients, studying the supply and demand on the market of veterinary products, working with clients and suppliers of raw materials, and working on the production and quality of its products. The first major step was the completion of construction and putting into operation of production plant of injectable drugs in 2004. The projection, construction and equipping the plant with all necessary equipment was carried out according to the project and in accordance with the requirements of GMP.

For the implementation of GMP standard "Vetsintez" LLC created a quality department, which is started creating and improving the Quality Management System of the company based on the requirements of ISO9001. As part of the Quality Management System, additionally developed and introduced the techniques and company’s standards according to GMP guidelines.

As a result of purposeful, focused planning work of company’s team, in 2006 “Vetsintez” successfully passed the official certification audit of Quality Management System of the company and the conformity with (State standards of Ukraine) SSTU ISO 9001, and received the first Ukrainian conformity certificate of developed quality management system - DSTU ISO 9001-2001.

However, the company did not stop there and continued the improvement of the existing quality management system. The number of customers is increased gradually, and respectively, the ambitions grew. The requests for our products started to come from overseas customers.

The top management has decided to improve the performance of the company. And a serious and painstaking work began on the expansion and restructuring: increasing the number of staff, determination and allocation of different departments in the company, reviewing and developing the functional responsibilities of personnel, outlining and planning the development prospects.

As a result of such great effort, the International Quality Management System certificate has been received in 2009, in accordance to the requirements of ISO 9001-2008 and this made it possible to promote the products to foreign markets.

"Vetsintez" - one of the first companies-manufacturers of veterinary medicines, which started to conduct a comprehensive work on the implementation of GMP rules and requirements in production practice. For their implementation in "Vetsintez" a large and laborious work was carried out, including the implementation of the basic principles of good manufacturing practice. And as a result, in 2013, the GMP certificate has been received. This enabled "Vetsintez" to represent its products not only in CIS, but also throughout the world.

This situation became possible only because the management and specialists of the company have always understood that the veterinary products are medications, especially when it comes to injectable preparations and, hence, their quality must meet the highest standards.

Working in order with suppliers, the principle of "clean rooms", constant production and external quality control of the manufactured medicinal products, the order delivery to the consumer - these, and many other elements of Good Manufacturing Practice (GMP), have always been for us the main foundation, which ensuring the high quality of our products.

Since one of the major prerequisites for the successful implementation of GMP standards in the company is a comprehensive personnel training on the theory and the practice of the standard, the company's management decided to start the work from here.

The training system in the company is a multilevel system of interconnected internal and external training, the emphasizing the development of programs, which considering the organizational matters of the production and the quality control of preparations from the standpoint of GMP rules and principles.

For this purpose we invite experts from external organizations to conduct training within the company, and the management ensures that all specialists are attending these trainings visiting at leading educational centers. On a regular basis, the personnel is provided with the professional trainings and periodic advanced training for specialists from different departments and divisions on the basis of initial and periodic training programs. All employees who are entering into the production, storage and quality control zones are attending trainings and knowledge-tests on the hygiene and sanitation procedures. The training system, which includes periodic coaching and briefings, is constantly being improved in order to prevent human error.

One of the most laborious, and critical challenging tasks during the implementation of the rules of good manufacturing practice is the process of creating and maintaining the documentation.

The company is developing and constantly improving the documents management system. The basic documents of the quality management system that was developed are:

• Quality policy and goals,
• Quality Manual - a document, which describes the company's quality management system in accordance with the requirements of ISO 9001 and the links to the main procedures;
• Regulations of subdivisions, job descriptions;
• Site Master File;
• Company standards and standard operating procedure that describes the following:

• management of documentation and records;
• internal audits (self-inspections);
• interrelations with customers;
• purchasing of raw materials;
• personnel management
• control of production process;
• quality control of raw materials and finished products;
• reception and storage of substances, raw materials and finished products;
• management and control of nonconforming products;
• corrective and preventive actions;
• recall and refund the product;
• analysis and test by senior management;
• monitoring, measurement and analysis of the of the quality management system processes, etc.

For continuous monitoring of the production process we created and constantly improving a documenting system of the production process, which consists of a set of documents that reflect the performance of all manufacturing and inspection operations with the release of each batch of finished products (dossier of production series).

The area - in which the production of preparations is carried out - are fully equipped with modern high-performance pharmaceutical equipment from the best international companies, as well as they are provided with clean production areas.

All measuring equipments, which used in the technological process, undergo metrological certification at specified intervals.

Independent control of the incoming raw materials, manufacturing process and finished products at the productions site provided by the Quality Control Department, which included two laboratories - chemical-analytical and bacteriological, that has a highly qualified personnel, among whom are doctors of veterinary medicine, doctors of bacteriology, a chemist-analyst, controller of medical products and of course the Head of Quality Control Department.

                                      

Each employee - who enters the manufacturing areas - wears protective clothing and personal protective equipment, according to the operations and the cleanliness class of the area.The entrance in clean rooms and working with substances and auxiliary materials is permitted only for special personnel through gateways system and sanitary inspection rooms with appropriate protective clothing and using modern individual protective means. Changing clothes in clean rooms is performed according to the requirements of safety and good manufacturing practices.

Каждый сотрудник, который входит в производственные зоны, носит защитную одежду и средства индивидуальной защиты, соответствующую выполняемым ею операциям и классам чистоты. 

                                                         

The important elements of the proper organization of medicines manufacturing process are the technical systems of the production, such as air and water monitoring and preparation. The purity of the air in the clean room is provides multiple system of air purification.

There are two systems of water preparation on the production site - system producing purified water by filtration "reverse osmosis" and a system that producing water for injections via distiller, which corresponds to the American and European Pharmacopoeia. During the manufacturing process there is a constant intraproductive monitoring.

According to established requirements of quality control department, we do select the required number of samples for the final analysis of finished products. Such analysis is performed in the chemical laboratory Vetsintez Ltd., as well as in the laboratory of the State Scientific-Research Control Institute of Veterinary Medicinal Products and Feed Additives (Lviv city). Upon receiving the analysis results, the quality control department confirms the quality of manufactured products by issuing the quality certificate of the finished product. Only after that the veterinary medication can leave the quarantine warehouse of finished products, and reach the consumer.

                                                   

To be able to track the movement of products, we do maintain distribution protocols and records, which are part of the dossier for the manufactured batches of drugs.

The stability control of the products when they arrive on the market is carried out in accordance with our program of further stability test.

At "Vetsintez" LLC, to analyze potential problems on different manufacturing processes stages, on the equipment's operation, etc., we conduct risk assessments on a regular basis. Using special methods of risk analysis our professionals evaluating the probability of problems, its impact on the quality of the products and the opportunity to correct the problem.

In order to confirm compliance with the requirements of Good Manufacturing Practice (GMP), the Quality Department conducts self-inspection of all departments of the company in accordance with the approved program, which is made in such a way to check each department in the established manner. Corrective or preventive actions are assigned depending on the results.

the company regularly conducts "quality days", where the discussion goes about all the results of the work to improve the products, the internal audit of the departments, the analysis of received complaints from consumers if any, and the outcome from the work with suppliers to improve the quality of raw materials and other issues to ensure the quality.

To determine the suitability, adequacy, efficiency and the effectiveness of the quality management system in the company, the head and senior management analyzes the company's work annually, in which we consider the following:

• audits results;
• performance indicators of interaction with customers;
• the functioning of processes and the conformity of products;
• status of preventive and corrective actions;
• subsequent actions arising from the previous analysis of the QMS;
• changes that could affect the quality management system;
• recommendations for improvement.

Based on the result of this analysis, we do come with decisions that relate to increasing the effectiveness of the quality management system and organization processes; improvement of the production, according to customer requirements; and resource requirements.

Thus, the activities of our company is constantly being reviewed and improved in order to achieve a high quality level of product that satisfies consumers.