GLP and GMP Compliant Sequencing
The Gold Standard For Non-Clinical Safety Studies.
GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) Sanger sequencing is primary designed to verify and confirm the sequence of specific DNA regions of interest. Whether it is validating a newly discovered genetic variant, confirming genotyping results, or verifying the identity of a genetically engineered organism, this service offers a gold standard approach for attaining high-confidence sequence data, especially for preclinical and regulated studies. By utilizing a stringent GLP framework, we guarantee the reliability and reproducibility of the data generated, ensuring accurate interpretation and decision-making.
Services
Benefits
Our GLP-compliant sequencing services include:
- Quality control of incoming DNA
- Design and synthesis of required primers
- Double strand sequence confirmation (2fold or 4fold coverage) by primer walking or by PCR amplification and sequencing
- Guaranteed accuracy of final data: 2fold coverage: > 99.999% and 4fold coverage: > 99.99999%
- Nucleic acid extraction, reverse transcriptase or DNA cloning are available on demand.
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Licenses & Accreditation
Eurofins Genomics US is an accredited GMP laboratory #3009882691 and adheres to the highest quality standards.
Eurofins Genomics US meets or exceeds the FDA guidelines for GLP (Good Laboratory Practice) regulations, as set forth in the FDA compliance standards 21CFR58. The United States FDA does not administer a formal licensure, accreditation or registration process or requirement for GLP laboratories. Eurofins Genomics maintains the required quality management systems, functional positions, and documentation standards to adhere with FDA GLP standards. In addition, Eurofins Genomics carries additional quality standards in ISO 9001 and ISO 13485. ISO 17025 is also available from our European faculty if necessary for your project.
Our expertise and experience is just one of the reasons why our GLP certified sequencing service is excellent for non-clinical laboratory studies. Our GLP sequencing service includes the following features:
- Fully validated procedures and equipment
- Regularly equipment calibrations
- Continuous personnel training on SOP's and procedures
- Restricted laboratory access
- Established SOP's and program procedures
- Complete study documentation
- Complete sample tracking for uncompromised sample and data integrity (chain of custody)
- All studies are inspected by our independent quality assurance department
- Comprehensive reporting including study plan and final study report