CONTROL LABORATORY
ANALYTICS AND QUALITY CONTROL
Sincrofarm has a technical team at the Service of Quality to manufacture both Medicines and Food Supplements, complying with the quality standards of the current Regulations throughout the entire process, analyzing from raw materials, through the intermediate product, to reach the final product.
Regulations
- GMP’s
- FSSC: 22000
- GMP’s Food
- FDA
Quality control
- Control of raw materials and finished products.
- Environmental and surface control.
- Water Control.
- Suitability Testing.
- Transfer of analytical methods
- Analytical controls of cleaning validations.
Analysis
- Chemicals: Markers, Impurities and related substances, Heavy Metals, Nutritional Analysis, TOC (Total Organic Carbon), Dissolution test.
- Physical-Chemical: Granulometry, Hardness, Density, Humidity, pH, Viscosity, Disintegration, Residue by calcination, Loss on drying, Dissolution test, Conductivity, Friability, Flow velocity, Angle of repose, Hausner index, Compressibility index.
- Microbiological: TAMC, TYMC, Salmonella, Staphylococcus aureus, Enterobacteriaceae, Pseudomonas aeruginosa, Escherichia coli, Listeria.
Equipment
- TOC/IR/dissolution test/disintegrator.
- Liquid chromatography: HPLC – DAD, UHPLC-UV-VIS, HPLC-RID.
- Gas Chromatography: GC-FID-flame ionization
The Quality Control Laboratory has both qualified personnel and the necessary equipment to control finished products and raw materials in compliance with pharmaceutical quality and food safety specifications:
· European Pharmacopoeia
· Regulation (EC) Nº 1881/2006”
