Manufacturing process and traceability
When you order oligos manufactured under GMP conditions from IDT, you receive the highest standards of traceability. The controlled and validated process is governed by the Oligo Master Record (OMR)—our collaborative playbook for how we produce your oligos every time you order.
When working with our GMP team, you can define and monitor all aspects of the manufacturing process of your product. As a GMP customer, you will have access to:
- World-class LIMS batch records for every order
- Hard-copy analytical QC documentation on every oligo
- Long-term quality agreements and contracts to ensure a stable supply of high quality GMP oligos
Legal and regulatory guidance
A quality GMP team should help you manage the regulatory and legal burdens that exist in the diagnostics space. Our facilities are ISO 13485:2003 certified and compliant with US FDA Quality System Regulation 21 CFR, Part 820. We maintain an “open door” audit policy.
Our common regulatory solutions include:
- On-site product or process audits with our Quality Assurance team
- Validation programs for all equipment and processes
- A rigorous product-release process managed by our Order Verification and Release team
You can obtain our industry-leading synthesis technologies, manufacturing capabilities, and technical expertise as a comprehensive third-party OEM service. Have custom-formulated products with your own labels and packaging shipped directly to your customers.