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EXPERIENCE OF CERTIFICATION BIOANALYTICAL LABORATORY ACCORDING TO REQUIREMENTS OF GOST 33044-2014 «PRINCIPLES OF GOOD LABORATORY PRACTICE» (GLP)

Abstract

Certificate of compliance to GOST 33044-2014 "Principles of Good Laboratory Practice" issued by an internationally recognized, competent and independent certification body serves, is one of the criteria for the selection of the contractor and the guarantee of the quality of services provided to many customers, as one of the mandatory conditions and exit organization development at the global, national or sectoral markets. This paper describes the first experience of GLP-certification for Russian bioanalytical laboratory.

About the Authors

A. A. Krylatova
Center of Pharmaceutical Analytics Ltd
Russian Federation


I. E. Shohin
Center of Pharmaceutical Analytics Ltd
Russian Federation


E. P. Obrazcova
Certification Association «Russian Register»
Russian Federation


A. O. Monaenkov
Certification Association «Russian Register»
Russian Federation


References

1. ГОСТ Р 33044-2014. Принципы надлежащей лабораторной практики. - М.: Стандартинформ, 2015. 16 с.

2. Сертификация систем менеджмента // Ассоциация по сертификации «Русский Регистр». URL: http://www.rusregister.ru/services/ms-certification/ (дата обращения: 29.09.2016).


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For citations:


Krylatova A.A., Shohin I.E., Obrazcova E.P., Monaenkov A.O. EXPERIENCE OF CERTIFICATION BIOANALYTICAL LABORATORY ACCORDING TO REQUIREMENTS OF GOST 33044-2014 «PRINCIPLES OF GOOD LABORATORY PRACTICE» (GLP). Drug development & registration. 2016;(4):218-221. (In Russ.)

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ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)