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FDA DNA Sequencing


fda dna sequencing DNA sequence analysis to support product applications to the FDA is available. Our procedures and standards are compliant with US FDA regulations covering GLP (21 CFR 58). The service includes a comprehensive DNA sequence analysis as described in individual project protocols with SOPs that cover all procedures staring with sample receipt to data delivery and archiving. Each project is guided by a designated Study Director who oversees all the steps of the work from sample receipt to final data delivery. Each project is evaluated by our independent Quality Assurance Unit personnel to ensure the quality and integrity of the study.

FDA Submission Quality DNA Sequencing Service features:

  • Double strand DNA sequencing by primer walking with 4-8 fold redundancy
  • Sequencing primers designed every 300-400 bases
  • Scoring raw sequence data and selection of PHRED 30- Phred 40 quality bases higher than 99.9-99.99% base call accuracy
  • Assembly and alignment of sequence data with Phred scored data
  • Determination of a consensus sequences
  • Archival of all project documentation in our FDA repository for auditing purposes

Project Reporting and Documentation features:

  • Sequencing procedure and strategy
  • Consensus DNA sequence
  • Contig alignment map showing sequence redundancy
  • Original electropherograms
  • A quality assurance (QA) statement
  • Original electropherograms and Phred scored data
  • Hard copy, pdf file, and CD of Final Report

Data archival at the study’s conclusion as detailed in Title 21 CFR that includes:

  • Storage of original sample
  • Hard copy of the final protocol, Final Report and any amendments
  • Laboratory notebooks containing all raw data
  • All computer generated data
  • Study correspondence
  • Statistical records
  • An original signed protocol, final report, an original signed report, the study correspondence and all raw data captured on durable media
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