cGMP OLIGOS

Oligos Etc. has a Quality Program designed to be compliant with FDA regulations and ISO standards. Oligonucleotides ordered with the intended use of “GMP,” “ASR” or “QS Reg” are manufactured to these requirements. A feature of OEI’s stringent Quality Program is individual Design Plans and Product Specifications for each oligo with batch records documenting process controls to predefined acceptance criteria. As a product release criteria, the Quality Assurance team verifies that the Design Plan, Product Specification and Quality System requirements have been met. A Certificate of Analysis is provided with each lot that meets these conditions.