Approved by the Order of the Center for the state supervision of pharmaceutical and medical activities (with the right of service) of May 2, 2007 No. 4

Regulations on procedure for certification and accreditation of laboratories of health care system

1. Scope

1.1. This Provision is developed according to the Item 5 "Provisions of the Center for the State Supervision of Pharmaceutical and Medical Activities (with the Right of Service)", No. 183 approved by the Order of the Government of the Republic of Tajikistan of April 3, 2007.

1.2. This document establishes:

- requirements to the organizations exercising quality control of narcotic and psychotropic drugs, precursors, pharmaceutical products, products of medical and sanitary and hygienic appointment, products of treatment-and-prophylactic food, nutritional supplements and cosmetics which are component of the Center for the state supervision of pharmaceutical and medical activities (with the right of service) (further the Center), and also laboratories of quality control of medicines and analytical tables of pharmaceutical institutions, clinical, biochemical, serological, bacteriological, immunological and other laboratories of system of the Ministry of Health of the Republic of Tajikistan, other laboratories on quality control of narcotic and psychotropic drugs, precursors, medicinal, diagnostic, preventive and cosmetics, medical goods and goods of sanitary and hygienic appointment, products of treatment-and-prophylactic food, nutritional supplements and cosmetics, and also analytical tables of pharmaceutical institutions irrespective of patterns of ownership and departmental subordination (further - laboratories or analytical tables);

- organization and procedure for carrying out certification and accreditation of laboratories and analytical tables;

- functions of the right and obligation of the certified and accredited laboratories and analytical tables;

- procedure for monitoring procedure behind the certified and accredited laboratories and analytical tables.

1.3. Certification and accreditation of laboratory is carried out according to articles 5 and 11 of the Law of the Republic of Tajikistan "About public health care", article 8 of the Law of the Republic of Tajikistan "About certification of products and services", the item 5 "Provisions of the Center for the State Supervision of Pharmaceutical and Medical Activities (with the Right of Service)" approved by the Order of the Government of the Republic of Tajikistan of April 3, 2007 No. 183.

2. References to regulating documents

This provision is developed according to requirements of standards of the Republic of Tajikistan of ST of PT 5.4-94 "Accreditation of examinees of laboratories (centers). Basic provisions".

3. The determinations used in the Provision

Hereunder, the following terms and determinations are used.

Accreditation of laboratory - the procedure by means of which the authorized body officially acknowledges the possibility of accomplishment by ispytuyemy laboratory of specific works in the declared area is official recognition of technical competence and independence of laboratory of developers, manufacturers and consumers of products or its technical competence in the carried-out specific types testing in the field of health care according to requirements of standards or other regulating documents.

Certification of laboratory - complex assessment of laboratory for the purpose of determination of area of her technical competence of carrying out specific types of testing in the field of health care and compliance of the requirement of standards.

Accreditation criterions - set of requirements to which there shall correspond the laboratory to be accredited.

Accreditation body of laboratories - the organization having official powers to carry out certification and accreditation of laboratories and to exercise inspection check-up behind their activities.

Accredited laboratory - laboratory which underwent the procedure of accreditation;

The certificate of accreditation of laboratory - the document which is issued to laboratory by accreditation body after carrying out accreditation of laboratory.

The certificate of compliance - the document which is issued to laboratory or analytical table by accreditation body after carrying out certification of laboratory.

The certificate of conformity to professional requirements - the document of single sample confirming compliance of training of the specialist to qualification requirements.

4. General provisions

4.1. Certification of laboratory or analytical table is official recognition of their technical competence of carrying out specific types of testing in the field of health care according to requirements of standards or other regulating documents.

4.2. Accreditation of laboratory is official recognition of technical competence and independence of laboratory of developers, manufacturers and consumers of products or its technical competence of carrying out specific types of testing in the field of health care according to requirements of standards or other regulating documents.

4.3. Each laboratory or analytical table performing the activities in the area specified in item 1.2 of this provision shall be certified or accredited.

4.4. The laboratories performing the activities before statement of this provision shall be certified without fail on technical competence. In case of expansion of sphere of activity such laboratories shall be accredited without fail.

4.5. Certification, accreditation and inspection check-up behind activities of the laboratories which are carrying out specific types of testing in the field of health care are carried out by the Center for the state supervision of pharmaceutical and medical activities (with the right of service).

4.6. In case of certification of laboratory or analytical table the certificate of compliance establishing area of her technical competence and compliance to requirements of standards is issued to them.

4.7. In case of accreditation of laboratory on technical competence and independence, or only on technical competence the certificate of accreditation in the established form is issued to it.

4.8. In case of accreditation the area of accreditation of laboratory by specifying of the name of the tested products and regulating documents regulating requirements to products and methods of its testing is established.

4.9. The requirements of certification and accreditation established by the this document are general and if necessary can be concretized proceeding from specifics of activities of these laboratories.

4.10. The certified or accredited laboratory or analytical table perform the activities according to the "Regulations on laboratory or analytical table" developed based on this document.

4.10.1. The regulations on laboratory determine area of accreditation, the right, obligation, responsibility of laboratory and other aspects of its activities and shall contain the following Sections:

1. General provisions

2. Main objectives and tasks of laboratory

3. Functions of laboratory

4. Rights and responsibility of laboratory

5. Structure and management

6. Claims

7. Archive

8. Confidentiality

9. Reorganization and liquidation

4.10.2. The regulations on analytical table area of accreditation, also shall contain the following Sections:

1. General provisions

2. Main functions of analytical table (office)

3. Sphere of activity of analytical table (office)

4. Requirements to personnel

5. Archive

4.11. Effective period of the certificate of accreditation or the certificate of compliance shall not exceed 5 years.

5. Criteria of certification and accreditation of laboratories and analytical tables

5.1. The accredited laboratory shall meet the following requirements:

- have the legal position providing its independence of applicants. The compulsory provision of ensuring independence of laboratory is absence at laboratories of joint commercial interests with applicants. In case the laboratory is not legal entity, it shall be structural division of the organization which part it is;

- have the organizational structure including system of quality assurance, reliability of the carried-out testing and also confidentiality of results of the carried-out testing,

- the laboratory shall not have commercial or other interest concerning ispytuyemy products, and also exclude possibility of rendering on employees of the illegal pressure capable to affect their conclusions or results of work.

5.2. When carrying out certification and accreditation also availability of the conditions providing technical competence is taken into account. The conditions providing technical competence are:

- availability of "Provision on laboratory", "Passports of laboratory", "Quality manuals" approved in accordance with the established procedure;

- availability of the head of laboratory who has education in the field of pharmacy, chemistry, microbiology and other adjacent specialties at least three-year work experience in this area;

- availability at the head of laboratory sufficient for management of laboratory of the rights in case of the solution of personnel and financial problems;

- the head of laboratory bears legal, administrative and disciplinary responsibility for confidentiality and objectivity of results of work and timeliness of accomplishment of the tasks assigned to this laboratory.

- availability of the specialists having sufficient professional training, qualification, work experience and providing carrying out measurements and testing in the established amount;

- availability of the approved job descriptions for the specialists of laboratory and documents concerning questions of advanced training of personnel. The staff of laboratory shall be certified in accordance with the established procedure. Certification of personnel of laboratory is performed by commission of experts of the Center for the state supervision of pharmaceutical and medical activities with involvement of experts-auditors. To the certified employees the certificate in the established form is issued;

- compliance of premises of laboratory to requirements of the regulating documents concerning accomplishment of conditions of carrying out testing including compliance to requirements of safe engineering, health protection and the environment. Access to the venue of testing, and also admission conditions to rooms of persons which are not belonging to personnel of laboratory shall be controlled.

- availability of the conclusions of sanitary and epidemiologic and fire supervision about compliance of premises of laboratory (analytical table) to sanitary and hygienic regulations and requirements of fire safety;

- availability of the necessary gages (G) and the test equipment (TE) for carrying out testing and measurements in all respects, determining area of accreditation and certification. The SI and IO shall be provided with certification and checking, and also possibility of their repair;

- availability of confirmation of suitability of use of the SI and IO;

- availability of documentation concerning accounting of the SI and IO, standard samples, schedules of their checking;

- availability of the corresponding regulating documentation regulating requirements to the tested products, techniques of carrying out testing;

- availability of system of quality assurance, related activity of laboratory, to amount of the performed works;

- availability of the approved instructions for labor protection and safe engineering;

- in laboratories the system of identification providing registration of samples for the analysis, sampling shall be effective (if necessary special storage conditions of samples, procedure and control procedure of storage conditions shall be provided);

- acceptance procedures, storages, returns, utilizations and write-offs of the objects of research arriving on the analysis shall be established;

- in laboratory the order of registration of the samples which arrived on control, results of check of their quality with settlement data and protocols of analyses shall be established;

- in laboratory the procedure for storage of documentation with results of quality check, magazines, protocols of analyses, reports on control and another shall be established;

- legality of results of quality evaluation at all stages of control shall be provided (exception of corrections, identification of signatures, seals, dates, etc. requirements).

5.3. The laboratories undergoing only certification shall correspond to the criteria specified in item 5.2 of this provision.

5.4. In case of certification of analytical table the following is considered: availability of "Provision on analytical table", "Passports of analytical table", "Quality manuals" approved in accordance with the established procedure;

- availability of the specialists having sufficient professional training, qualification, work experience and providing carrying out measurements and testing in the established amount;

- availability of the approved job descriptions. Employees of analytical table shall be certified in accordance with the established procedure. Certification is performed by commission of experts of the Center for the state supervision of pharmaceutical and medical activities with involvement of experts-auditors. To the certified employees the certificate in the established form is issued;

- room compliance to requirements of the regulating documents concerning accomplishment of conditions of carrying out testing including compliance to requirements of safe engineering, health protection and the environment. Access to the venue of testing, and also admission conditions to rooms of persons which are not belonging to personnel of pharmaceutical institution shall be controlled.

- availability of the necessary gages (G) and the test equipment (TE) for carrying out testing and measurements in all respects, determining area of accreditation and certification. The SI and IO shall be provided with certification and checking, and also possibility of their repair;

- availability of confirmation of suitability of use of the SI and IO;

- availability of documentation concerning accounting of the SI and IO, standard samples, schedules of their checking;

- availability of the corresponding regulating documentation regulating requirements to the tested products, techniques of carrying out testing;

- availability of the system of quality assurance corresponding to the carried-out analysis types of analytical table, amount of the performed works;

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