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RESOLUTION OF THE CABINET OF MINISTERS OF THE AZERBAIJAN REPUBLIC

of February 6, 2006 No. 34

About approval of the List of indicators of safety and quality of blood, components of blood and the medicines prepared from them and the Procedure of control of compliance of blood, components of blood and the medicines prepared from them to indicators of safety and quality

(as amended of the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of 08.05.2021 No. 141)

For the purpose of ensuring execution of Item 1.10 of the Presidential decree of the Azerbaijan Republic "About application of the Law of the Azerbaijan Republic "About donorship of blood, components of blood and service of blood" of July 18, 2005 the No. 263 Cabinet of Ministers of the Azerbaijan Republic decides:

1. Approve "The list of indicators of safety and quality of blood, components of blood and the medicines prepared from them" and "Procedure of control of compliance of blood, components of blood and the medicines prepared from them to indicators of safety and quality" it (is applied).

2. This resolution becomes effective from the date of signing.

Prime Minister of the Azerbaijan Republic

A.Раси-Заде

Approved by the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of February 6, 2006, No. 34

The list of indicators of safety and quality of blood, components of blood and the medicines prepared from them

Name of indicator       

Explanations        

1. Safety        


2. Quality


3. Quality assurance


4. Quality Management System (QMS)


 

5. Quality control   


6. Efficiency  

 

7. Performance                


8. Possibility of tracing         

 

9. Audit                             


10. Self-assessment                       


11. Check of professional knowledge 


12. Standard operational procedures


13. Statistical control          

 

14. Control of blood transfusion   

                                                                              

the correct observance of indicators of quality degree of compliance of indicators of requirement part of quality management, is directed to quality compliance to requirements; covers factors which can exert separately or together impact on product quality the management system directing the organization in respect of quality and exercising control of it. For achievement of reliable and visible quality, it is necessary to organize SUK providing realization of consecutive quality assurance and documentation part of quality management, it is directed to compliance of indicators to requirements. Unites in itself the sampling, the specification, carrying out inspection, at the same time organizational tests, tests of documentation, compliance and transaction providing non-admission of materials for use before quality confirmation implementation of the planned activities and extent of achievement of the planned results comparison of the used resources to the received results possibility of tracing of date of production, use and placement of the provided products receipt of materials for the purpose of determination of degree of compliance to the corresponding criteria and the permanent independent process of documentation which is carried out for objective assessment, means of check whether really work is conducted by the accepted rules within protocols and procedures comprehensive and constant control of results of activities by the organization and comparison of results to various systems. It can help with identification of the sites needing enhancement the Special monitoring tool for check of competence of employees of laboratory of implementation  of the tasks delivered before them and is carried out by means of all stages of transactions brought from anonymous laboratory tests the instruction of carrying out the means specifying the arising changes in production process or the procedure consists of identification, collection and the analysis of data on undesirable and unexpected impacts of blood transfusion in time there is connection of control of blood transfusion with control over drugs and goes for processes after supply of components of blood, provides  interconnection between medical institution and the producer for the purpose of consecutive enhancement.

 

Approved by the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of February 6, 2006, No. 34

Procedure of control of compliance of blood, components of blood and the medicines prepared from them to indicators of safety and quality

1. General provisions

1.1. The medical institutions performing transfusion to the recipient of blood, components of blood and the medicines prepared from it exercise control of observance of indicators of safety and quality of these products. In order that these products were safe and useful, all production stages (procurement, processing, storage, transportation and release) shall be carried out by the rules approved by the Ministry of Health of the Azerbaijan Republic.

1.2. The purpose of creation of control systems behind safety and quality of blood, components of blood and the medicines prepared from them serves the prevention of any negative, undesirable moments during blood transfusion, to implementation of their analysis, enhancement on chain of blood transfusion and increase in safety of all process of blood transfusion.

1.3. Quality of the developed components of blood depends on two major factors:

* from requirements to products;

* from the quality management systems which are reliably providing accomplishment of relevant requirements to products.

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