GLP – The Gold Standard For Non-Clinical Safety Studies

Good Laboratory Practice - GLP

GLP – The Gold Standard For Non-Clinical Safety Studies

DNA sequencing services for registration or licensing purposes.

Good Laboratory Practices (GLP) defines the general guidelines for the conduct of non-clinical health and environmental safety studies for the following: drugs, pesticides, vaccines, gene therapeutics and genetically modified organisms (GMO) for the purpose of registering or licensing.

Meet the demands of regulatory authorities with GLP

The main focus of GLP is to ensure that test data is reliable, repeatable and auditable and is easily recognised by scientists and authorities worldwide.

Your benefits

Full traceability of GLP study data
GLP compliant archiving of study data and records
Full compliance with GLP regulatory requirements (OECD)
Acceptance of non-clinical safety study data by regulatory authorities in OECD member states

Key requirements of GLP

Test facility management (TFM)
Study director (SD)
Archivist
Independent quality assurance unit and QA program
GLP compliant study conduct and study inspection
GLP compliant study documentation (protocol, report, SD and QA statements)
GLP archive (archiving period >15 years)
GLP training

GLP focuses strongly on the traceability and safety of the original test data (raw data) as well as clear responsibilities.

Compliance with GLP is achieved through certification by a national GLP authority and independent internal inspections (QA program).

Eurofins Genomics committed to delivering products, services and applications that are at the highest quality.

The GLP standard is applied to the following Eurofins Genomics products and services offering:

DNA/RNA quantification for safety testing of GMOs, microorganisms, viruses, cell banks and cell lines
DNA sequencing for genotyping and safety testing of GMOs, microorgansims, viruses, cell banks and cell lines

Downloads

GLP Certificate Eurofins Genomics Europe Pharma and Diagnostics Products & Services Sanger/PCR GmbH