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Quality | Quality system | Quality control |
Starting materials, intermediate, bulk and finished products are sampled and tested.Starting materials are not released for use, nor finished products released for sale or supply, until their quality has been judged as satisfactory.
Besides, in-process controls are carried out and recorded.
In order to control the particulate cleanliness and the microbiological cleanliness, the areas are monitored.
Employees who work in clean areas are subjected to additional microbiological monitoring.
Quality Control is independent of Production.
Quality Control Equipment:
| HPLC chromatographs | Centrifuges | |||
| IR Spectrophotometers | Microscopes | |||
| UV-Visible Spectrophotometers | Steritest | |||
| Autoclaves | LAL testers | |||
| Microbial Air Samplers | Conductivity instruments | |||
| Freezers | Friability testers | |||
| Refrigerators | Particle counters | |||
| Baths | TOC | |||
| Laminar air-flow cabinets | Atomic absorption spectrometers | |||
| Disintegration testers | Gas chromatographs | |||
| Dissolution testers | Viscometers | |||
| Hardness testers | Pycnometers | |||
| Aerosol test apparatus | Automatic titrators | |||
| pH meters | Incubators | |||
| Analytical balances | Melting point apparatus | |||
| Karl-Fischer apparatus | Ovens | |||
| Refractometers | Polarimeters | |||
| Capillary electrophoresis | Lims |
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