FDA DNA SequencingACGT offers DNA sequencing analysis to support product applications to the U.S. Food & Drug Administration (FDA). Our standards and procedures comply with FDA regulations mandating Good Laboratory Practice (GLP) as codified at 21 CFR § 58.

FDA submission-quality DNA sequencing is detailed in our proprietary Standard Operating Procedures (SOP) that govern our service from sample receipt to data delivery and archiving. Each project is executed with the oversight and management of a designated Study Director and evaluated independently by a Quality Assurance Unit (QUA) to ensure its quality and the integrity of our processes.

Features of FDA Submission Quality DNA Sequencing:
  • Double strand DNA sequencing by primer walking with 2 to 8 fold redundancy
  • Sequencing primers designed every 300 to 400 bases
  • Scoring raw sequence data and selection of Phred 20 to Phred 40 quality bases (base call accuracy equal to or higher than 99.00 to 99.99%, respectively)
  • Assembly and alignment of Phred-scored sequence data
  • Determination of consensus sequences
  • Archival of all project documentation in our FDA repository for auditing purposes
Features of Project Reporting and Documentation:
  • 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 Data CD of Final Report
Data Archival at the conclusion of the Study (per Title 21 CFR):
  • Original test articles for a minimum of 2 years
  • 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