Locations inspection manufacturers

drugs

Conducting GMP audits in order to
prepare for the upcoming inspection
by the national inspectorate... More

 

The geography of our audits covers

Russia and CIS countries

Western and Eastern Europe,
countries of Southeast Asia and
the Middle East, India, Japan

Federal Service for Supervision in Healthcare did not agree with the conclusions of Russian Quality System about the masks low protection properties against viruses.

GMP News

 

Roskachestvo conducted a study to determine the viral and microbial permeability of medical masks from four manufacturers. The researchers determined the level of filtration (in dry and wet form) and additionally tested the masks for strength, breathability, and hygroscopicity.

 

 

 

    Roskachestvo found out that in terms of effectiveness against bacteria, medical masks are highly effective and comply with GOST (National State Standard). At the same time, in the study of viral permeability, none of the products even showed a result of less than 70%.

 

     “The best result is for a medical mask type 1 “Non-woven materials”, it passes up to 77.39%. And the worst is at the medical disposable mask "Moscow Endocrine Plant". Its throughput capacity is 93.86%. This mask will trap less than 7% of viruses,” Roskachestvo points out.

 

     Roszdravnadzor did not agree with the conclusions of Roskachestvo, calling into question the ability of masks to protect against viruses. A message was posted on the service’s website stating that the information disseminated by Roskachestvo “does not contain information confirming the validation of the applied method for assessing the viral permeability of medical masks, which casts serious doubt on both its correctness and the results obtained during its application.”

 

     “Currently, the normative documents of the technical regulation of the Russian Federation do not contain a requirement and a method for testing the virus permeability for medical masks,” the message says.

 

     Roszdravnadzor emphasizes that all masks that have passed state registration and have a regulatory certificate used in the Roskachestvo study “passed all the necessary tests, which allows us to guarantee their quality, safety and effectiveness.” 

All news

 
 

8-495-004-50-76

105064, Moscow, Nizhny Susalny lane, 5, p.19 room XI, room.2

info@gmp-project.ru

Sitemap

"GMP-Project" - a company that specializes in assisting in the preparation of the inspection of manufacturers of medicinal products for compliance with the rules of good manufacturing practice, the activity of which is located outside the Russian Federation.