Quality program

Services performed at IBR Inc. are compliant with Good Laboratory Practice (GLP) standards and ICH guidelines. Analytical data and reports of IBR Inc. are accepted by regulatory authorities worldwide.
The IBR Inc. quality system is characterized by a consequent life cycle management of procedures and documents allowing continuous adaptations to the requirements of the clients and regulatory authorities.

The quality system is based on the following principles:

  • Stringent in house procedure
  • Continuous scientific and quality training of our personnel
  • Qualified and calibrated equipment
  • Sound procedures, protocols and reports
  • Validated analytical procedures
  • Use of controlled and traceable materials
  • Traceable receiving and storage of samples
  • Well-structured system for “out of specification” (OOS) results
  • Document archiving (10 years)

The quality system of IBR Inc. insures transparent conduction of studies from planning, to laboratory execution and to reporting. IBR Inc. offers a comprehensive validation program of routine and customized assays according the ICH Q2 (R1) guidelines. Validation data can be reviewed at the facility. In addition, IBR Inc. offers sample-specific validations.

Quality standard of IBR Inc. is routinely audited by:

  • Internal inspections
  • Client’s audits (USA/EU)
  • Regulatory authorities

 

Downloads

Statement_of_GLP-Compliance_2017  [PDF, 197 KB]

Statement_of_GLP-Compliance_2014  [PDF, 468 KB]

Statement of GLP-Compliance 2011  [PDF, 454 KB]

Statement_of_GLP-Compliance_2008  [PDF, 377 KB]

Statement_of_GLP-Compliance_2006.pdf   [PDF, 223 KB]

Statement_of_GLP-Compliance_2003.pdf   [PDF, 100 KB]

Statement_of_GLP-Compliance_2001.pdf  [PDF, 89.0 KB]