cGMP and ISO 13485
The use of Molecular Diagnostics is growing at approximately 11% annually, and with it the need for oligonucleotides that can be used in diagnostic tests. This rapidly growing demand has driven the need to understand the requirements for oligos used in diagnostic testing and to discriminate between what is required by law in the US and what is not required but prudent when purchasing oligos for use in medical diagnostics. At the heart of this question is the difference between Good Manufacturing Practices (GMP) and ISO 13485 certification and what these credentials mean for oligonucleotides manufactured for human diagnostics (Table 1).
A consumer often must trust his life to a medical device or rely on a diagnostic test for critical health information. To ensure such devices and tests are safe and effective, the Food and Drug Administration (FDA) established quality system regulations under the Code of Federal Regulations (CFR), Title 21, Part 820, which detail the legal requirements for how medical devices and diagnostic tests are manufactured. Among other requirements detailed in the CFR, the manufacturer must have a system in place that documents the validation/control of all processes. They must also acknowledge any change in their processes, and record, track, and correct the production of products as necessary. This set of actions is referred to as Good Manufacturing Practice (GMP) and requires extensive validation and record keeping. For GMP facilities producing finished devices, GMP regulations are not optional but are required by law. With a registered GMP facility, IDT ensures that our GMP oligonucleotides are manufactured in compliance with these regulations, as appropriate.
The International Organization for Standardization (ISO) is a voluntary, non-governmental organization that provides unified standards for many different areas of industrial activity. The ISO 13485 designation is the standard for manufacturers of medical diagnostics. While similar to GMP in many respects, holding an ISO 13485 certification is not a legal requirement, but is accepted as an international standard. Manufacturers are continually audited and must be recertified on a regular basis. The regular audits ensure that the reported standards of manufacturing are maintained and encourage continuous improvements. The IDT Clinical and Commercial Manufacturing (CCM) division has been certified to ISO 13485:2003 since 2008 (ref. BSI certificate FM 513219).
Table 1. Comparison of GMP vs. ISO 13485.
IDT Oligonucleotides for Diagnostics Applications
IDT Clinical and Commercial Manufacturing division (CCM) is ISO 13485:2003 certified and registered with United States Food & Drug Administration (FDA) as a contract manufacturer of oligonucleotide components for in vitro diagnostic devices (IVDs) and analyte-specific reagents (ASRs) for laboratory developed tests (LDTs). What does this mean for customers purchasing oligos for use in human diagnostics? GMP manufacturing compliance and ISO 13485 certification provide proof that the manufacturer has a system in place to validate and provide traceability for oligonucleotide manufacturing history during the production process. This in turn helps to ensure that the oligonucleotide quality and specifications are consistent and reproducible. These certifications indicate that IDT quality system requirements and product realization plans align with the needs of our customers requiring oligos for regulated or diagnostic end-use applications.
The IDT CCM division partners with our human diagnostics customers to define the oligo characteristics that will work best for their diagnostic applications. We provide guidance on process scale-up for deliverable yields of a few nmoles up to multiple grams. Our CCM division also boasts supplemental services such as dedicated purification columns, aliquoting and other custom packaging, and oligo mixture formulation.
Contact our CCM group to discuss your GMP oligo needs at email@example.com or visit our webpage under the Products menu at www.idtdna.com.
Author: Mitch Gore is the Clinical and Commercial Specialist at IDT.