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.
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.
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:
Client’s audits (USA/EU)
Adequate sample management policy is an essential piece of a GxP compliant test facility.