VUAB Pharma a.s. offers improvement free capacities our chemical and microbiological laboratories
Chemical laboratories (GLP certificate)
Chemical analyses according to European Pharmacopoeia, US Pharmacopoeia
- Gas chromatography
- High pressure liquid chromatography
- Spectrophotometry (UV-VIS, IR)
- Distribution of particle size
- Chemical analysis of water
- Other tests
- Free capacities of stability boxes (different temperature and humidity)
Microbiological laboratories (GLP certificate)
Microbiological tests according to European Pharmacopoeia
- test for sterility:
- membrane filtration, Millipore steritest
- direct inoculation of the culture medium
- microbial contamination of non-sterile products, air, gases and water
- microbiological assay of antibiotics
- Limulus Amebocyte Lysate (LAL) test
- other tests:
- microbiological monitoring of manufacturing facilities
- microbiological monitoring of clean rooms
Validation
VUAB Pharma a.s. offers validation activities (validation of clean rooms, temperature fields) conformable with The Rules Governing Medicinal Products in the EuropeanUnion.
Volume IV, Medicinal Products for Human and Veterinary Use: Good Manufacturing Practices, Annex 15: Qualification and Validation