Good laboratory practice , GLP ( English good laboratory practice ) - a system of norms, rules and guidelines aimed at ensuring the consistency and reliability of laboratory research results. The system is an approved national standard of the Russian Federation from March 1, 2010 - GOST 33044-2014 [1] .
The main task of GLP is to provide the possibility of complete tracking and recovery of the entire course of the study. Quality control is called upon to be carried out by special bodies periodically inspecting laboratories for compliance with GLP standards.
GLP sets very stringent documentation and recordkeeping requirements - significantly more stringent than the European standards of the EN 45000 series. The scope of application of the GLP norms is established by law. This primarily relates to the development of new chemicals, the production and use of toxic substances and health care.
Content
Scope
This standard establishes the principles of good laboratory practice for use in non-clinical testing of objects contained in medicinal substances, pesticides, cosmetic products, veterinary drugs, food and feed additives, as well as industrial chemicals. The tested drugs can be of a synthetic nature, as well as of biogenic origin, as well as represent living organisms.
In conjunction with the standards of GMP (Good Manufacturing Practice) and the GCP (Good Clinical Practice), is designed to standardize some aspects of the quality of public health services.
Development History
The GLP system has been operating for over 20 years. Initially, the GLP system of standards was developed and put into effect by the US Food and Medical Industry Administration ( FDA ) in relation to industries that use toxic substances in order to eliminate the inconsistencies in the regulatory documentation. GLP regulations became mandatory for all companies in the United States and, subsequently, in countries that export their products to the United States. Then, through the efforts of the Organization for Economic Cooperation and Development ( OECD ), these standards began to spread internationally. In particular, in Germany, GLP requirements are mandatory when developing any new types of chemical products.
Since May 6, 2017 in the Eurasian Economic Union , uniform rules of good laboratory practice (GLP) for the production of medicines [2] came into force.
Notes
- ↑ GOST 33044-2014 Principles of Good Laboratory Practice, GOST dated November 20, 2014 No. 33044-2014 Unsolved . docs.cntd.ru. The appeal date is June 7, 2017.
- ↑ Vasily Boytsov (Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission) . Regulatory documents of the EAEU take into account the best international practices , Rossiyskaya Gazeta (05/19/2015). The date of appeal is November 16, 2015.
See also
- HL7 (medical standard)