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:
- ISO 22000
- GMPs in Food production
- FSSC (certification process underway, scheduled for February 2020)
- Technical supervision and validation of all manufacturing processes.
- Document management.
- PQR (Product Quality Review)
- Validation of cleaning procedures.
- Support in the preparation of dossiers.
- Internal audits.
- Supplier accreditation.
- Control of Raw Materials and Finished Products.
- Analytical methods validation and development.
- Environmental and surface control.
- Water Control.
- Suitability Test.
- Process 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
- Microbiological (Class C room): TAMC, TYMC, Salmonella, Staphylococcus aureus, Enterobacteriaceae, Pseudomonas aeruginosa, Escherichia coli.
- Liquid chromatography: HPLC-DAD, UHPLC-UV-VIS, HPLC-RID
- 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