QM services & QM standards

QUALITY IS CONTINUAL IMPROVEMENT

The entire area of quality management—including quality planning, quality control and quality assurance—makes an important contribution to improving your efficiency. Here, we offer consulting, preparation, implementation and maintenance of QM systems in the fields of GCP, GLP, GMP, GVP and GDP according to the following standards: 

    • GCP (Good Clinical Practice as defined by the European Directives 65/65/EEC, 75/318/EEC, 2001/20/EC and 2005/28/EC)
    • GLP (Good Laboratory Practice as defined by the DIN EN ISO 15189 and DIN EN ISO/IEC 17011)
    • GMP (Good Manufacturing Practice as defined by the European Directive 2001/83/EG, 2005/28/EC , the EU GMP Guideline, Annex 13 and the EudraLex Vol. 10 Clinical Trial Guidelines - Quality of the Investigational Product - guidance on IMPs and other medicinal products used in clinical trials)
    • GDP (Good Distribution Practice) TRS Nr. 957, Annex 5 (2010), TRS No. 961, Annex 9 (2011), EU GDP Guideline 05.11.2013
    • ISO 9001 (all clinical research areas)
    • ISO 14155 (medical devices)
    • ISO 13485 (in-vitro diagnostics)
    • Pharmacovigilance (Regulation (EC) No 726/2004, Directive 2001/83/EC, Commission Implementing Regulation (EU) No. 520/2012, Good Pharmacovigilance Practice (GVP), ICH and national regulations)
    • FDA standards
    • EMA standards
    • WHO standards
    • National regulatory requirements

The support we offer is used by pharmaceutical/biotech companies, institutions, medical practitioners, medical care centres, University clinics and hospitals.

 


Quality is not accidental, but the result of systematic commitment.

Günther Puffer

How to find us

Contact


SwissPharmAudit GmbH
Fischpicke 1
57482 Wenden
Germany

Fon: +49 (0) 2762 98 35 220
Fax: +49 (0) 2762 98 35 222
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SwissPharmAudit (Schweiz) GmbH
Roesliweg 11
88404 Winterthur
Switzerland

Fon: +41 (0) 43 388 89 65
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