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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).

Our quality system meets the most stringent requirements from regulatory authorities.

ISO 9001

ISO 9001

ISO 9001 falls into ISO 9000 family of quality management systems (QMS) standards. It is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.

ISO 9001 is a general standard and one of the most basic standards that an organization can adopt. ISO 9001:2016 is the last version of the ISO 9001.

GENERI BIOTECH has implemented ISO 9001 in 2006. Since then GENERI BIOTECH is annually audited by independent notified body to confirm that our QMS is in compliance with the standard ISO 9001.

In June 2019, GENERI BIOTECH has been audited to be in compliance with ISO 9001:2015 (view certificate).

 

 

ISO 13485

ISO 13485

ISO 13485 (Medical devices — Quality management systems — Requirements for regulatory purposes) is an ISO standard valid from 1996. It represents the requirements for a comprehensive QMS for the design and manufacture of medical devices.

GENERI BIOTECH has implemented ISO 13485 in 2012. Since then GENERI BIOTECH is annually audited by independent notified body to confirm that our QMS is in compliance with the standard ISO 13485.

In June 2019, GENERI BIOTECH has been audited to be in compliance with EN ISO 13485 ed.2:2016 (view certificate).

 

ISO/IEC 17025

ISO/IEC 17025

ISO/IEC 17025 specifies the general requirements for the competence of testing and calibration laboratories. ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.

GENERI BIOTECH has implemented ISO/IEC 17025 in 2016. Since then GENERI BIOTECH is regularly audited by independent notified body to confirm that our QMS is in compliance with the standard ISO/IEC 17025.

In May 2019, GENERI BIOTECH has been audited to be in compliance with ISO/IEC 17025:2005 (view certificate) . 

GLP

GLP

GLP refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical and pharmaceuticals non-clinical safety tests. Laboratory tests under GLP are mostly required by companies developing new drugs.

GLP system is audited by national drug and administration authority.

In March 2018, GENERI BIOTECH obtained Certificate of good laboratory practice with scope of activities: Non-clinical studies others –  Molecular biological methods (view certificate).

GMP

GMP

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.

GMP system is audited by national drug and administration authority.

In June 2018, GENERI BIOTECH obtained two Certificates of GMP compliance of a manufacturer (view certificate No.1, 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.