Quality Assurance and Quality Control

cGMP Quality Control Testing/analytical quality control laboratories fully equipped to conduct test programs for pharmaceutical clients, according to the pharmacopoeia (e.g. EP,SUP,BP and JP) and to in-house specifications for raw materials (excipients and active pharmaceuticals ingredients), finished
Products and intermediate products, packaging materials, purified and tap water.
We offer a wide range of analytical techniques, including the following key techniques
Chromatography
- TLC
- HPLC/UPLC (with UV,PDA, RI Detectors)
- GC/HS (with FID Detectors)
Spectroscopy
- UV/Vis
- IR, FTIR
- Atomic absorption spectroscopy – flame/graphite/VGA
- MALDI TOF mass spectrometry for microbial identification
- TOC (Total Organic Carbon) analysis
Chemical, Physical and physiochemical testing services
- Assay and Purity (e.g. Chromatography, Titration, Limit Tests)
- Identity (e.g. Spectroscopy, Chromatography)
- Dissolution Test (On Line/Off Line)
- Pharmaceutical Water Analysis (e.g. TOC)
- Water Content (Loss on Drying,
- Disintegration, Friability
- Appearance (e.g. Clarity, Opalescene)
- pH and Conductivity
- Uniform of Mass etc.
Microbiology testing:
Microbial Limits Tests
- Microbial Contaminant Identification
- Preservatives Testing And Microbial Challenges
- Bacterial Endotoxins
- Environmental Monitoring
- Water Systems Validation
- Production Facility Qualification
- Cleaning Validation
Pharmaceutical Quality Assurance
Business consulting in the process of establishing the system of quality management according to national and international standards (ISO 9001, ISO 14001, ISO 18001, cGMP)