In 2022, PROTEINA completed the construction of a production facility that adheres to Good Manufacturing Practice (GMP)
standards and has been producing biochips, buffers, and reagents at the facility since.
PROTEINA operates a Quality Management System (QMS)
electronic documentation system
standardized procedures, guidelines,
and forms
Product performance inspection and
real-time sharing
Corrective and preventative actions
Quality assurance system
Good Laboratory Practice (GLP)
PROTEINA has built a GLP system that meets the U.S. FDA’s GLP criteria (21 CFR Part 58).
This means that non-clinical trials that are carried out through PROTEINA services can be submitted to the FDA.
PROTEINA’s electronic quality management system (QMS) ensures all relevant documentation is digitally preserved and
that all appropriate employees receive relevant training
The ISO/IEC 27001 standard provides companies of any size and
from all sectors of activity with guidance for establishing, implementing, maintaining and
continually improving an information security management system.