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 with GLP certified testings
- Full traceability of GLP study data
- GLP compliant archiving of study data and records
- Full compliance with GLP regulatory requirements (OECD, EMA, US-FDA, US-EPA)
- Acceptance of non-clinical safety study data by regulatory authorities in EU, US and 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)
- 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:
|Pharma & Diagnostics
- Pharmacogenetics & pharmacogenomics
- Assay development & validation
- Biological safety testing
- Genetic stability testing (GST)
- Diagnostic kit and device validation (for e.g. FDA and patent submissions)
- Analysis of production strains (inserted DNA, transcriptome)
|Agriculture & Food
- Plant breeding
- Food production & retail
- Analysis of GM plants / food and feed for submission
- Residual host cell and pathogen DNA & RNA analysis
- GMO & genetic insert characterisation
- Basic genomic characterisation
- Metagenomic & genetic characterisation
- Microbial detection and differentiation
The GLP standard is applied to the following Eurofins Genomics products and services offering: