Omnichem has a long history of good track records with FDA. The 3 sites were in total inspected by the American Authorities 17 times.
OmniChem QC organization is working on a corporate basis with Quality control teams active on each of the 3 manufacturing sites of OmniChem.
The QC units operate according to GMP standards (ICHQ7a) in support of commercial productions.
Responsibilities and tasks of the department :
Analysis of ...
Raw materials
Intermediates
Final products (incl. APIs)
Cleaning samples
Stability samples
Exemple of equipment available on site :
HPLC (connected to client-server network / 21CFR11)
GC incl. Headspace, GC-MS (connected to C/S network 21 CFR11)
LC-Diode Array - MS – ELSD
Ion chromatography (Metrohm)
300 MHz NMR,
Potentiometric titrators (Metrohm)
Volumetric and coulometric KF
UV spectrophotometer (Perkin-Elmer)
FTIR (Perkin Elmer)
Polarimeter (Perkin Elmer)
TLC automatic sampler and scanner (Camag)
Particle size analyser – laser diffraction (Malvern, dry and wet cell)
Stability cabinets (Rumed)
Other: (analytical) balances, pH, melting point app, pH,
Lovibond colourmeter, viscosity-meter, ovens, muffle furnaces, ...