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Quality management
The Company has implemented the Quality Assurance System that provides the principles for as well as determines the actions, which influence the quality of fabricated therapeutic products, so that they satisfied the registration requirements and GMP guidelines. Furthermore, the System guarantees that the produced pharmaceutical preparations are effective and safe and demonstrate the highest world quality.
At present the System is being adapted to the requirements of the Pharmaceutical Law, dated 6 September 2001, which are in compliance with the European Union regulations pertaining to production of pharmaceuticals.
The System is described in following documents:
- Quality Policy,
- Quality Book,
- System Procedures,
- Standard Operating Procedures (SOPs).
The Quality Assurance System covers the following key issues:
- personnel,
- key staff,
- production rooms and equipment,
- production,
- quality control,
- complaints and product withdrawal,
- documentation,
- internal audits,
- qualification of suppliers.
In accordance with the Company’s Development Strategy for the years 2000-2003, in 2001 as well as this year a number of investment projects were continued in order to improve the products quality, maintain the GMP standards and fulfil the requirements being consequence of developing new pharmaceutical forms. In the Ampoules Department there were constructed a new section for liophilisation and aseptic filling as well as installation for production and distribution of purified water and injectable water.
In the Tablets Department modernisation and validation works were completed at the sugar-coating section, there was also purchased numerous pieces of production process equipment. Furthermore, the Company accepted a conception for extension and modernisation of that department in order to enable development of new pharmaceutical forms.
At present a technical design is developed.
 In order to adjust the laboratory working conditions to the requirements of Good Laboratory Practices (GLP), in June 2002 a new building of Research Laboratory was set into operation. Concurrently, there was executed the project of general modernisation of laboratories of the Quality Control Department (completion expected in 2003).
The modernized laboratories will comply with the EU standards concerning: making analyses, validation of analytical methods, certification of quality, performing contracted analyses, carrying out tests for clinical research, validation of production processes at the stage of development and implementation of new technologies.
In April 2003, Pharmaceutical Manufacturing Inspectors of the Manufacturing Inspection Department at the Chief Pharmaceutical Inspector controlled the Company’s Ointment Department with respect to fulfilment and maintenance of production conditions in accordance with the requirements of Good Manufacturing Practice.
The outcome of inspection was positive. Hence, the Ointment Department was granted a certificate confirming fulfilment of the GMP and QA requirements as well as compliance of its production conditions with international standards (WHO, EU, PIC/S).
QUALITY POLICY
The Quality Policy of Jelfa is pursued in order to fulfil expectations of our customers, shareholders and employees. The main objective is to produce effective, safe and top quality pharmaceutical preparations in an environment friendly manner. This is the only way to achieve the Company’s success.
We implement that objective through:
- establishment and continuing improvement of the Quality System at all the stages of production and control, with regard to thestate regulations and current guidelines of Good Manufacturing Practices, which ensure that our customers receive products that are in compliance with appropriate quality standards as well as registration and concession requirements;
- fostering possibly the best human relations among our employees, increasing their qualifications as well as creating conditions for individual responsibility for the quality of products;
- continuing analysis of our customers' needs and seeking optimum ways to fulfil them;
continuing improvement of production conditions as well as introduction of modern and verified technologies.
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