quality


Quality philosophy

Quality philosophy

The Vifor Pharma quality management system is designed to provide our customers with

_safe products of high quality
_compliance to international standards
_high customer satisfaction

This quality philosophy is carried throughout the organisation, with the objective to provide products according to defined specifications within the delivery terms and conditions required, fulfilling all regulatory expectations (GMP, EU, medical devise_ISO 13485:2003 and ISO 9001:2000).

Quality assurance

Quality control

Vifor Pharma quality organisation will support customers in

_all product aspects such as process and analytical method validations, follow-up stability studies, annual product reviews
_all batch release activities (e.g. batch record review, establishment of certificates)
_all modifications or product improvements through change-management, supplier audit and qualification.

Quality control

Quality assurance

VIfor Pharma laboratories are able to perform product anlaytics using methods for

_active substance analysis
_characterisation
_physical parameters, chemical analysis
_microbiological tests

The analytical laboratory is equipped with facilities for all state-of-the-art analytical methods such as liquid and gas chromatography (HPLC), near-infrared spectrophotometry (NIRS), atomic absorption, UV/VIS spectrophotometry.

We carry out method transfers and take over the analytical accompaniment of the process transfer. Microbiological assessments are carried out on-site. For special testing, we have established close collaboration with specialised thir-party service providers.