Analytics and Quality ControlPlaymedic2019-11-18T08:12:38+00:00
Analytics and Quality Control
Sincrofarm’s technical team is dedicated to providing a high Quality Service in Medicines and Food Supplements manufacturing, adhering to the quality standards of the current regulations:
GMPs in Food production
FSSC (certification process underway, scheduled for February 2020)
Technical supervision and validation of all manufacturing processes.
PQR (Product Quality Review)
Validation of cleaning procedures.
Support in the preparation of dossiers.
Control of Raw Materials and Finished Products.
Analytical methods validation and development.
Environmental and surface control.
Finished Product Control
Chemicals Markers, Impurities and Related Substances, Heavy Metals, Nutritional Analysis, TOC (Total Organic Carbon), Dissolution Test
Physical-Chemical: Granulometry, Hardness, Density, Humidity, pH, Viscosity, Disgregation, Loss on ignition, Loss on drying, Dissolution test, Conductivity, Friability
Flow rate, Angle of repose, Hausner index, Compressibility index
Gas chromatography: GC-FID-flame ionisation, GC-ECD-electron capture, GC-FTD-Nitrogen-Phosphorus
The Quality Control Laboratory has both, the qualified staff and equipment to reach the highest standards in concerns of finished products and raw materials controls, adhering to pharmaceutical quality and food safety specifications:
• European Pharmacopoeia
• Regulation (EC) No. 1881/2006”
Physical-Chemical Analysis Room: Granulometry, Viscosity, Disgregation, Dissolution test and Friability
Microbiological Analysis Room
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