23.02.2012
Quality Assurance
GE Pharmaceuticals goal is to provide products with pre-set quality.
The Quality Management System ensures control of all incoming materials and the finished products before their release for sale.
The QA department
- controls the production activities in compliance with the established Standard Operating Procedures;
- proposes reviews and updates in accordance with GMP and all regulatory requirements;
- executes the deviation and change control;
- initiates investigations of market complaints and the appropriate actions to be taken.
Quality Control Pharmaceutical tests of solid drug productsAverage weight and uniformity of weight
Disintegration
Friability
Hardness
Dissolution
Identification, assay and content uniformityUV-Vis spectroscopy, HPLC with UV-detection, GC with FID-detection
Impurities UV-Vis spectroscopy, HPLC with UV-detection, GC with FID-detection
Residual solventsGC with FID-detection
Water contentKarl Fischer Titration
Additional TestsTLC for identification of drug substances, colorants, exipients etc., purity, semi-quantitation
Wet chemical analysis for identification of drug substances, colorants, exipients etc., limit tests
Microbiological quality control
Activities and ServicesDevelopment and validation of analytical methods
Technical and methodological support
- controls the production activities in compliance with the established Standard Operating Procedures;
- proposes reviews and updates in accordance with GMP and all regulatory requirements;
- executes the deviation and change control;
- initiates investigations of market complaints and the appropriate actions to be taken.
Quality Control Pharmaceutical tests of solid drug products
Identification, assay and content uniformity
Impurities
Residual solvents
Water content
Additional Tests
Activities and Services
