Quality Assurance (GLP/GCP)

In order to garantee the best quality performance to our customers, Swiss BioQuant practices comprehensive and systematic quality management. Quality as a significant attribute of performance is the result of careful planning and subject to constant controls by our internal quality assurance group.

The Quality assurance unit performs regular inspections for all GLP and/or GCP compliant studies and facility inspections are conducted several times a year. 

Swiss BioQuant was successfully inspected by the Swiss authorities (Swissmedic) in July 2008 stating the GLP compliance of the test facility according to the Swiss Ordinance relating to Good Laboratory Practice, adopted May 18th, 2005 [RS 813.112.1]. This Ordinance is based on the OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26th, 1997 by decision of the OECD Council [C(97)186/Final].

 

Swissmedic GLP compliance certificate 2008
Swissmedic certificate 2008.PDF (1.05MB)
Swissmedic GLP compliance certificate 2008
Swissmedic certificate 2008.PDF (1.05MB)
Swissmedic GLP compliance certificate 2011
Swissmedic certificate 2011.pdf (1.59MB)
Swissmedic GLP compliance certificate 2011
Swissmedic certificate 2011.pdf (1.59MB)
Swissmedic GLP compliance certificate 2014
Swissmedic certificate 2014.pdf (523.79KB)
Swissmedic GLP compliance certificate 2014
Swissmedic certificate 2014.pdf (523.79KB)
Swissmedic GLP compliance certificate 2016
Swissmedic certificate 2016.pdf (365.38KB)
Swissmedic GLP compliance certificate 2016
Swissmedic certificate 2016.pdf (365.38KB)




For the bioanalytical part of a clinical study the principles of GCP are followed as described in the EMA Reflection paper.

 

regulatory documents

EMA guideline for bioanalytical method validation
EMA guideline on bioanalytical method validation.pdf (158.77KB)
EMA guideline for bioanalytical method validation
EMA guideline on bioanalytical method validation.pdf (158.77KB)
EMA GCP reflection paper
EMA Reflection paper on GCLP.pdf (135.23KB)
EMA GCP reflection paper
EMA Reflection paper on GCLP.pdf (135.23KB)
FDA guidance for bioanalytical method validation
Guidance for industry - method validation.pdf (110.95KB)
FDA guidance for bioanalytical method validation
Guidance for industry - method validation.pdf (110.95KB)