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.

Key requirements of GLP accreditation

The requirements of GLP Accreditation are similar to ISO 17025 with some additions:

• 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 or state GLP authority and independent internal inspections (QA program).

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

Good Laboratory Practice is the highest QA standard Eurofins Genomics offer to their customers. If submission or registration to national authorities is necessary then GLP compliance allows us to conduct non-clinical safety testing for the following applications:

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

• Custom DNA Sequencing
• Next Generation Sequencing