Our Quality Standards

Services performed at IBR Inc. are compliant with the following quality standards:

Good Laboratory Practice - GLP

The IBR Inc. laboratories are GLP compliant since 2001 and directed by our in-house Quality Assurance Manager. Services and method validations under IBR Inc. GLP procedures are performed in compliance with the Swiss Ordinance relating to Good Laboratory Practice (GLP), 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]. Regulatory authorities worldwide accept IBR Inc.’s analytical data and reports.

Good Clinical Practice - GCP

The quality standard of Good Clinical Practice has been introduced at IBR Inc. in 2012 and follows the EMA Guidance (EMA/INS/GCP/532137/2010, 28 Feb 2012). Analysis of clinical trial samples must be performed using appropriately validated methods with adequate acceptance criteria according to Good Clinical Practice requirements.

The quality system

The quality system relies on the following principles:

  • Stringent in-house procedures and quality control of data
  • 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. ensures transparent conduction of studies from planning, to laboratory execution and reporting. IBR Inc. has proofed proficiency in assay validation. With regard to assay development and validation we apply the principles of ICH Q2 (R1), USP 1032, 1033 and 1034.

A consequent lifecycle management of procedures and documents allowing continuous adaptations to the regulatory authorities and client’s requirements characterizes the IBR Inc. quality system.

Quality standard of IBR Inc. is routinely audited by:

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

Adequate sample management policy is an essential piece of a GxP compliant test facility.

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