Pharmaceutical production is a complex technological process, and the quality of manufactured products highly depends to what extend each manufacturing stage is developed and performed. Exactly that’s why Quality Assurance Department is created and successfully operating in JV “Jurabek Laboratories” Ltd. Main task of this subdivision is to maintain such manufacture management system under which safety and effectiveness of produced medicine is provided at every stage of product life cycle. 

Principal functions of Quality Assurance Department of JV “Jurabek Laboratories” Ltd are:

• Providing the functioning of quality management system (QMS);

• Development of policy in the field of quality together with top management;

• Continuous training and raising the qualification of personnel;

• Conducting internal audits and self-inspections to supervise subdivisions observe requirements of international standards ISO 9001,and European Union GMP Directive;

• Validation of processes and equipment;

• Creation and maintaining of accurately arranged document circulation system;

• Periodical actualization of normative documents;

• Registration of medicines in the market of Uzbekistan and of foreign states in compliance with requirements of relative normative documentation;

• Providing products quality control from receiving of materials before and after sales of products;

• Audit of substance and packaging materials manufacturers;

• Providing products traceability after manufacture;

• Management of production and postproduction risks;

• Working with reclamations.

Also there have been determined main principles which Quality Assurance Department is governed with during its activity:

• Periodical analysis of effectiveness of quality management system and its continuous improvement;

• Raising of consumers’ satisfaction;

• Process approach and correlation of subdivisions, processes efficiency monitoring;

• Total involvement of personnel in quality management system in the company.

Work of Quality Assurance Department in JV “Jurabek Laboratories” Ltd at high level maintains the staff of officers represented by Quality Director, Head Auditor, Training Coordinator, Authorized Person, group of Documentation Officers and Registration Specialists. All of them are highly qualified specialists in their field, knowing their work and acting for the benefit of the company.

Note for reader

Validation – documented confirmation of compliance of equipment, manufacturing environment, technological process, quality of half-finished and finished product, with effective regulations and/or requirements of normative documentation.

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