IDT’s expertise in GMP manufacturing allows us to help you through every step of your assay development, from discovery to commercialization. We offer a streamlined portfolio to aid in GMP product selection, order processing, and transparent pricing.
Manufacturing process and traceability
IDT maintains an extremely high standard for traceability for the manufacturing of your GMP oligos. The controlled and validated process is governed by the Device Master Record Index—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
A quality GMP team should help you manage the regulatory burdens that exist in the diagnostics space. Our facilities are ISO 13485:2016 certified. We maintain an “open door” audit policy.
Our common regulatory solutions include:
- On-site product or process audits with our Quality Assurance team
- A rigorous product-release process managed by our Order Verification and Release team