GMP Legal and Regulatory Guidance

Our experts will manage your project progression from research to commercialization

For GMP facilities producing oligos for use in in vitro diagnostic devices or analyte-specific reagents, GMP regulations and guidance will often prescribe the requirements of the device inputs, and this includes oligos. With a certified GMP facility, IDT ensures that our GMP oligonucleotides are manufactured in compliance with these regulations, as appropriate.

Our team will help you manage the oligo related regulatory and legal burdens required in the diagnostic space. Our facilities are ISO 13485:2003 certified and compliant with US Food & Drug Administration (FDA) Quality System Regulation (QSR) 21 CFR Part 820, and we maintain an open door audit policy.  We also produce oligos that can be included in CE-marked kits and other commercial products.

Regulatory solutions from IDT include:

  • On-site product or process audits with our Quality Assurance team
  • Full LIMS batch record traceability for every GMP oligo
  • Validation programs for all equipment and processes
  • Rigorous Product Release process managed by our Order Verification & Release team
  • Hard-copy analytical QC documentation provided for all GMP oligos
  • Long-term quality agreements and contracts available to ensure years of stable GMP oligo supply