Regulatory compliant DNA sequencing

DNA and cDNA sequencing required for regulatory submission purposes need to be done by certified laboratories ina high quality environment .

cGMP/GLP compliant sequencing involves:

• Primer design to cover the entire region studied with sufficient overlapping, and in both orientations
• Alignment of the sequences into a contig with a minimum of four fold coverage for each nucleotide
• Manual reading of the sequences
• Consensus construction using quality criteria and minimum redundancy in the alignment
• Comparison with reference sequences
• Original approved raw data
• Complete report describing in detail sequencing strategy and variations
• QA statement
• QP approval