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.
- 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)
- 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