Spectrum's certification to ISO 9001:2015 and ISO 17025:2005
standards along with strict adherence to current Good
Manufacturing Practices (cGMP) form the foundation of our
Integrated QualitySM (IQ) program. All raw materials
and finished goods entering our facilities are subject to
stringent in-house testing in our analytical laboratories to
ensure all chemicals and ingredients meet our own high quality standards.
Spectrum’s extensive knowledge and
experience in the changing global regulatory environment ensures
that our products are compliant with the US FDA, DEA, ICH WHO
and other worldwide regulatory entities.
Quality - #1 Priority
actively supports Rx-360, an international pharmaceutical supply
chain consortium, and supports transparency in the supply
All of Spectrum’s global manufacturing and
distribution sites are FDA registered and operate under
current Good Manufacturing Practices (cGMP).
All Spectrum facilities are certified to the current ISO
9001:2015 quality standard.
Spectrum’s Shanghai, China analytical laboratory is
certified to the ISO 17025:2005 quality standard as an
independent third-party testing laboratory.
Spectrum is registered with the DEA as a manufacturer of
Controlled Substances (Schedules II - IV).
Spectrum regularly performs manufacturer site audits to
ensure batch-to-batch consistency.