Quality

Qualität

Quality philosophy

The quality management system of Vifor Pharma aims to provide our customers with:

  • Safe, high-quality products
  • Compliance with international standards
  • High customer satisfaction

At Vifor Pharma, we apply this quality philosophy company-wide. Our objective is to produce our products in accordance with predetermined specifications, the necessary delivery times and conditions and all supervisory standards (GMP, EU, ISO standards for medical devices, 13485:2003 and 9001:2000).

Quality assurance

Vifor Pharma's quality assurance supports customers with:

  • all product phases, including the validation of processes and analytical methods, follow- up stability studies, annual product reviews
  • all batch release activities (e.g. review of batch documentation, issuing of certificates) 
  • all product changes or improvements by change management, inspection and qualification of suppliers

Quality control

Vifor Pharma can carry out product analyses in its labs with methods

  • for analysis of the active substance 
  • for characterisation
  • to determine physical and chemical parameters
  • for microbiological tests

The quality control laboratory is fitted with equipment to carry out state-of-the-art analyses such as gas and liquid chromatography (GC/HPLC), near-infrared spectroscopy (NIRS), atomic absorption and UV/VIS spectrophotometry.

We carry out method transfers and guarantee analytical support for process transfers. Microbiological monitoring and assessments take place on site. We carry out special analyses in close collaboration with specialised third-party providers.

Contact

Vifor Ltd.

Contract Development & Manufacturing
Route de Moncor 10
P.O. Box
CH-1752 Villars-sur-Glâne

Phone:
+41 58 851 61 11
Fax:
+41 58 851 60 50

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