Approved by the Order of the Head of Service of the state supervision of pharmaceutical activities of November 19, 2008 No. 15

Regulations on procedure for carrying out accreditation, certification and inspection check-up of laboratories of field of pharmacy

This Provision is developed according to the item 5 "Provisions of Service of the State Supervision of Pharmaceutical Activities", No. 483 approved by the Order of the Government of the Republic of Tajikistan of October 1, 2008 establishes procedure for carrying out accreditation, certification and inspection check-up of laboratories, irrespective of patterns of ownership and the departmental subordination performing pharmaceutical activities.

1. General provisions

1.1. The determinations used in the Provision.

The following terms and determinations are hereunder used:

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

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

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

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

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

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

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

1.2. Certification of laboratory is official recognition of their technical competence of carrying out specific types of testing in health sector according to requirements of standards or other regulating documents.

1.3. 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 of health sector according to requirements of standards or other regulating documents.

1.4. Each laboratory, performing the activities in the field of this provision, shall be accredited or certified.

1.5. 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.

1.6. Accreditation, certification and inspection check-up behind activities of the laboratories which are carrying out specific types of testing in the sphere of pharmacy are carried out by Service of the state supervision of pharmaceutical activities.

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

1.8. 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.

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

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

1.11. The accredited or certified laboratory performs the activities according to the "Provision on laboratory" developed based on this document.

1.11.1. 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.

1.11.2. The regulations on pharmaceutical laboratory determine area of accreditation and shall contain the following Sections:

1. General provisions.

2. Main functions.

3. Sphere of activity.

4. Requirements to personnel.

5. Archive.

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

2. Accreditation criterions and certifications of laboratories

2.1. The accredited laboratory shall meet the following requirements:

- have the legal position providing its independence of applicants. The compulsory provision of ensuring independence of laboratories 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;

- 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 and results of work.

2.2. When carrying out accreditation and certification 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;

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