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Ministry of Justice

Republic of Tajikistan

On January 30, 2009 No. 478

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 in the field of health care 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 the field of health care 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.

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