Finetech Chemical meets the high quality requirements of its customers thanks to the strict adherence to a quality system based on the process approach of ISO 9001:2015, which includes GMP according to ICH Q7 as well as safety, health and environmental (EHS) protection.
As part of Finetech's quality management, the quality control unit is responsible for testing raw materials, intermediates and final products to ensure compliance with specifications. For each material an approved testing procedure is available which defines the different analytical methods, and their acceptance criteria. The tests are carried out according to GMP standards on qualified instruments that were calibrated in defined intervals. The process analytics unit is responsible for in-process tests as well as release of cleaning results. The Quality Assurance unit monitors compliance with GMP requirements such as review of batch records. Activities such as cleaning and process validation are performed by the responsible Quality Management project manager.
Main analytical methods
|◆ Liquid chromatography (HPLC)||◆Gas chromatography (GC)|
|◆Capillary electrophoresis||◆Thin layer chromatography (TLC)|
|◆ IR- and NIR Spectroscopy||◆ UV/VIS spectroscopy|
|◆ Titration (including Karl Fischer)||◆ pH|
|◆ Melting point||◆ Loss on drying|
|◆ Hazen (APHA color scale)||◆ Differential scanning calorimetry|
|◆ Specific pharmacopoeia tests||◆ Nuclear magnetic resonance(1H-, 13C, 19F-NMR)|
|◆ Liquid chromatography with mass spectrometry detection(HPLC-MS)||◆ Gas chromatography with mass spectrometry detection(GC-MS)|