Categories

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.

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 9001:2015 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 2024, a recertification audit was conducted at GENERI BIOTECH’s new premises to demonstrate compliance with the requirements of EN ISO 9001:2015 (certificates: ITC Zlin, CQS, IQNet).

ISO 13485:2016

ISO 13485:2016

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 October 2023, GENERI BIOTECH received a new quality system certificate from TÜV SÜD (certificate).

IVDR

IVDR

  • IVD medical devices

In October 2023 we received EU Quality Management System certification for IVDR medical devices class C (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 July 2024, GENERI BIOTECH obtained Certificate of good laboratory practice with scope of activities: Non-clinical studies others – Molecular biological methods (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 July 2024, GENERI BIOTECH obtained two Certificates of GMP compliance of a manufacturer (certificate HHLP, certificate HLP).

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