HI Luisa,

you raised a very good question that concerns many companies. A quality system is the backbone of any organization. it defines the structure of the organization as well as define the roles and responsibilities of each member in this organization. The SOPs provide employees with the required steps to achieve the quality defined in the quality system. In order to be GMP or ISO compliant, you have to have SOPs in place to define how GMPs can be achieved.

In research, SOPs are required to define data collection procedures, experiment setup, ensure collected data legibility and accuracy, and process repeatability. The absence of SOPs during experimentation may lead to miscalculation of data, misinterpretation of data, missed experiment steps, etc. Therefore, the presence of SOP is required to conduct any GMP experiment.