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Our Quality Standards

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

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.

Good Manufacturing Practice - GMP

IBR Inc. has been certified by Swissmedic in Q1 2019 for the conduction of studies on physical/chemical analyses, bioanalytics and microbioanalytics in compliance with Good Manufacturing Practice (GMP). Our system is compliant with the Swiss quality standard of GMP, which follows the EU GMP requirements (described in EudraLex, Volume 4, Good Manufacturing Practice guidelines) and with the FDA GMP requirements (Current Good Manufacturing Practice regulation for human pharmaceuticals).

The in-house Quality Assurance Manager and Responsible Person (Fachtechnisch verantwortliche Person, FvP, for Switzerland; Qualified Person, QP, within the EU); ensure the conduction of studies in compliance with EU and FDA GMP requirements.

      GMP Certificates      

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 proven 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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