GLP Microbial Identification

In September 2004, the Food and Drug Administration issued a strong guidance recommending genotypic identification of microbes as part of routine environmental monitoring programs for aseptic processing under GMP guidelines:

"Genotypic methods have been shown to be more accurate and precise than traditional biochemical and phenotypic techniques...Advanced identification methods (e.g., nucleic-acid based) are valuable for investigational purposes."--Pharmaceutical Current Good Manufacturing Practices (FDA Draft Guidelines 9/04).

GLP Microbial Identification Testing

According to Applied Biosystems (ABI), the variations within the gDNA coding regions of rDNA is sufficient to identify most organisms at the species level.  Microbial identification (ID) takes advantage of this variation to provide a rapid and accurate means for determining bacterial or fungal identity in pure cultures from rDNA sequencing data.  SeqWright employs the MicroSeq® 500 16S rDNA and MicroSeq® D2 LSU rDNA kits (ABI) for bacterial and fungal identification respectively, following manufacturer’s instructions.  After PCR amplification and sequencing with these kits, the sequence data is analyzed in ABI software with rDNA libraries to provide search reports containing percent match comparability to other microbes.

Reasons for Choosing SeqWright’s Microbial ID Service

• More than 14 years of experience specializing in contract DNA sequencing.
• 9 years of experience in offering FDA submission DNA sequencing.
• SeqWright is compliant with 21 CFR 58 and 21 CFR 11.
• SeqWright has implemented components of 21 CFR 210/211, including OOS.
• We guarantee fast turnaround for urgently needed answers with accurate results.

Additional Resources

• Learn more about SeqWright's Quality Assurance Program.
• FDA Submission DNA Sequencing.
• QPCR for microbial detection and quantitation.
• Contact a sales representative about this service.