Assessment of companies for compliance with the GMP, GDP, GVP, GLP requirements

GxP (Good Practice) Standard - covers all the stages of the life cycle of a medicinal product, starting from pharmaceutical development, testing, manufacturing, storage up to use by the end-user.

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GxP
(Good Practice)

a globally recognized system that ensure the quality of medicinal products. The system of GxP covers all the stages of the life cycle of a medicinal product, starting from pharmaceutical development, testing, manufacturing, storage up to use by the end-user, in particular:

Pre-clinical (laboratory) trials

Pre-clinical (laboratory) trials, which are regulated by the GLP Rules (Good Laboratory Practice).

Clinical trials

Clinical trials, which are regulated by the GCP Rules (Good Clinical Practice).

Production

Production, which is regulated by the GMP Rules (Good Manufacturing Practice).

Storage

Storage, which is regulated by the GSP Rules (Good Service Practice).

Wholesale trade

Wholesale trade, which is regulated by the GDP Rules (Good Distribution Practice).

Retail trade

Retail trade, which is regulated by the GPP Rules (Good Participatory Practice).

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GMP Standard Certificate

The GMP Certificate indicates that the products listed above are manufactured in strict compliance with the necessary chemical composition in those conditions that do not allow the foreign particle contamination, as well as properly packaged, which guarantees the preservation of all the properties during the entire shelf life.

Together with the GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) standards, this standard is intended to standardize certain aspects of the quality of public health service.

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We would like to draw the attention of the manufacturers to as follows: Starting from 01 September 2010, all the manufacturing sites are required to undergo certification in accordance with the law "On circulation of medicinal products", which implies the transition of all production facilities to internationally recognized GMP quality standards. The procedure of transition to the GMP standards should be completed in 2014, but there is a possibility of certification until 2015 -2016 for compliance with some individual requirements established by the law: Federal Law No. 61-FZ “On circulation of medicinal products” of 12.04.2010 (as amended on 29.12.2015).

What are the advantages of the GMP Certificate?

it increases the competitiveness of manufactured products
it stabilizes the quality of the products
manufacturers receive advantages for participation in tenders, events on a competitive basis

it increases the investment attractiveness of the products
it opens up opportunities to enter the global market
it improves the reputation of the company in the domestic market

Our specialists will conduct the GMP audit of the enterprise, consult you on the questions you are interested in to successfully pass the state inspection and obtain the GMP certificate.

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