Standards

We in GENERI BIOTECH believe that sustainable development of our company can be achieved also through permanent improving processes.  Below there is a list of standards for which GENERI BIOTECH is certified (accredited).

ISO 9001:2016 – general standard (view certificate)

EN ISO 13485 ed.2:2016 – standard for development and manufacturing CE IVD products (view certificate)

ISO 17025 – standard for non-GxP testing (view certificate)

GLP – Good laboratory practice – system audited by national drug and administration authority. Laboratory tests under GLP are mostly required by companies developing new drugs. (view certificate)

GMP – Good manufacturing practice – system audited by national drug and administration authority. It is required for those tests that are ordered by pharma companies to release a batch of a drug to the market. (view certificate, view certificate no.2)

GENERI BIOTECH is a holder of GMO Authorization according to Directive 2009/41/EC on contained use of genetically modified micro-organisms.