glp - ibacon · pdf filepractice. beyond that, ibacon gives benefit to the clients of its oecd...
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v
Next Level
for your GLP Lab
Guiding you safely
If you have specific questions or wish to get to know more about our portfolio, visit our website or give us a call.
ibacon GmbH ibacon GmbH Arheilger Weg 17 Kolberger Straße 61-63 D-64380 Roßdorf D-51381 Leverkusen
www.ibacon.com
Christiane Rutschmann-Fröhlich Head of Quality Assurance
phone: + 49 6154 697-381
email: [email protected]
Your business contact
Sabrina Westphal Head of Business Development Member of Board
phone: +49 6154 697-238
email: [email protected]
OECD Principles
The OECD Principles of Good Laboratory Practice ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations. The principles have been created in the context of harmonising testing procedures for the Mutual Acceptance of Data.
Experience
Our team of QA professionals is experienced in various GLP topics. Scientific education and constant training is the basis of a high level of qualification.
We are member of the German Society for Good Research Practice (DGGF) and present at different working groups, e.g. analytics, ecotoxicology, field studies, IT.
We think ahead – we think of you
www.ibacon.com
OECD
GLPcertified
since 1995
Standard Operating Procedures
• Preparation and revision of standard operating procedures
• Review of standard operating procedures on GLP conformity
Validation of Computerised Systems
• Advice and assistance on the development of validation standards and performance of validation process
Support for Authority Inspection
• Implementation of quality assurance systems for initial inspections
• Supervision of the first GLP study
• Review of existing GLP concepts and improvement of existing systems and processes
• Pre-inspection training and briefing of staff at all levels
We meet your needs
In-house Audits
• Support of internal QA
• In-house audits of studies and processes – specialized in studies for Environmental Risk Assessments
• In-house audits of facilities
Site and Vendor Audits
• Audit and/or pre-placement assessment of facilities at 3rd party Contract Research Organizations
Training
• Tailored to your needs
• GLP training on various topics
Quality Assurance Services
ibacon supports since 1994 chemical and pharmaceutical industries around their regulatory projects with efficient contract research and ERA-studies compliant to the OECD Principles of Good Laboratory Practice. Beyond that, ibacon gives benefit to the clients of its OECD GLP Certification not only by study performance, but also by direct Quality Assurance Services such as inspections of studies, laboratories and facilities up to complete external GLP-Services. Any operator of a GLP lab using our service safes not only own GLP-structures and staff, but can rely on the vast experience of our highly skilled QA-experts.
QA-Services for Environmental Risk Assessment Studies
• Aquatic and terrestrial ecotoxicology
• Physical and chemical parameter characterization
• Residue analysis
• Environmental fate
• Field studies
Our concept of external Quality Assurance includes advice and assistance on all aspects of quality assurance activities.