FOCUS Quality Assurance

The FOCUS Quality Assurance team ensures that all FOCUS facilities operate according to the highest quality standards of GXP.

FOCUS operates in compliance with:

ICH-GCP, Declaration of Helsinki, German Drug Law, EU-CT & GCP Directives, German GCP Ordinance
OECD principles of GLP, GLP Regulations embodied in the German Chemical Law (GLP Certification by local GLP Authority since June 1993)
EU GMP Directive (several inspections by the local GMP Authority)
ISO 9001:1994 certified by Lloyd's Register Quality Assurance Ltd May 95
ISO 9001:2000 recertified by Lloyd´s RQA Ltd. in Dec. 2003
ISO 9001:2008 recertified by Lloyd´s RQA Ltd. in Dec. 2009
audited by ADAMAS Consulting UK & Verdandi AG on behalf of BVMA in 2000/2003/2006/2009

The accountabilities of FOCUS QA cover:

assurance of GXP Compliance
regular internal system, facility and study audits
regular vendor audits
support of sponsor audits and cooperation with ISO 9001 certification body and regulatory authorities e.g. FDA
GXP auditing on a contract basis

FOCUS Quality Assurance The FOCUS Quality Assurance team ensures that all FOCUS facilities operate according to the highest quality standards of GXP. FOCUS operates in compliance with: ICH-GCP, Declaration of Helsinki, German Drug Law, EU-CT & GCP Directives, German GCP Ordinance OECD principles of GLP, GLP Regulations embodied in the German Chemical Law (GLP Certification by local GLP Authority since June 1993) EU GMP Directive (several inspections by the local GMP Authority) ISO 9001:1994 certified by Lloyd's Register Quality Assurance Ltd May 95 ISO 9001:2000 recertified by Lloyd´s RQA Ltd. in Dec. 2003 ISO 9001:2008 recertified by Lloyd´s RQA Ltd. in Dec. 2009 audited by ADAMAS Consulting UK & Verdandi AG on behalf of BVMA in 2000/2003/2006/2009 The accountabilities of FOCUS QA cover: assurance of GXP Compliance regular internal system, facility and study audits regular vendor audits support of sponsor audits and cooperation with ISO 9001 certification body and regulatory authorities e.g. FDA GXP auditing on a contract basis		FOCUS was inspected several times by the US-FDA, each time with a successful outcome and is audited about 10 to 12 times per year by Sponsors (from Europe, USA and Japan) and by German state authorities. The FOCUS QA team has over 20 years of experience as auditors. Our QA team consists of a founder member of the German Society for Good Research Practice (Deutsche Gesellschaft für gute Forschungspraxis = DGGF) and a full member of the British Association of Research Quality Assurance (BARQA). The Head of QA is also a CQA consultant.

Competence Centers

FOCUS Quality Assurance