GLP Certification for high quality sequencing services within the regulatory field

Carola Grimminger, Marketing Manager, Eurofins Genomics carolagrimminger@eurofins.com

Good Laboratory Practice (GLP) is the worldwide gold standard to conduct non-clinical health studies, including pharmacology and toxicological studies. Additionally, for pre-clinical safety studies GLP compliance is required for the development of pharmaceuticals (small molecules) and biologics (monoclonal antibodies, therapeutic proteins, vaccines and gene therapeutics). GLP standards are also critical for the development of diagnostic kits and device validation (FDA and patent submissions), as well as an array of other products including agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, and detergents.

Extended GLP certifications for Sequencing (Sanger & Next Generation)

Good Laboratory Practice is the highest QA standard Eurofins offers to their pharma and diagnostics customers. GLP ensures that test data is reliable, repeatable and auditable and is easily recognised by scientists and authorities worldwide.

As a result, in 2014 Eurofins Genomics added Next Generation Sequencing (NGS) to their ISO 17025 accredited testing portfolio. At the same time the company achieved GLP certification for DNA sequencing services, the first genomic service provider in Germany to attain such qualification.

Some months later AROS, a member of the Eurofins Genomics Group, has extended GLP certification for (NGS) services as one of the first service providers in Europe.

AROS has already been GLP certified since 2005 for their DNA and RNA extraction services, qPCR (Gene Expression and Genotyping) and microarrays (Illumina and Affymetrix). In 2015 they also added the certificate “non-clinical safety studies for medical products on NGS under GLP” to their GLP certified platforms.

With this comprehensive set of GLP certifications for sequencing services, Eurofins customers yield the combined full benefits of highly skilled staff, formal quality management and quality assurance systems and long-term experience.

For more information, visit www.eurofinsgenomics.eu