ISO DIS 20688-1
Biotechnology - Nucleic acid synthesis - Part 1: General definitions and requirements for the production and quality control of synthesized oligonucleotides
|Publication Date:||31 January 2019|
|ICS Code (Biology. Botany. Zoology):||07.080|
This document defines terms and specifies minimum requirements for the production and quality control of synthesized oligonucleotides (nominally up to 250 bases). This document also describes general quality attributes for synthesized oligonucleotides as well as common methods for evaluating quality attributes.
Although this document is primarily intended for the manufacturers of synthesized oligonucleotides to improve their quality management and to demonstrate product quality and consistency, it can also be used for other ISO accredited laboratories.
NOTE International, national or regional regulations or requirements also apply to specific topics covered in this document. For example, when synthesized oligonucleotides are used as investigational drugs or pharmaceutical agents, regional regulations and / or GMP are considered