Our Quality Standards
Services performed at IBR Inc. are compliant with the following quality standards:
Good Laboratory Practice - GLP
The IBR Inc. laboratories are currently not enrolled in the Swiss GLP monitoring program. Re-enrolment is planned for 2026.
IBR Inc. originally established GLP compliance in 2001 and maintains an independent in-house Quality Assurance function responsible for oversight of quality systems, procedures, and data integrity.
Where activities are performed under IBR Inc.’s GLP framework, services and method validations are conducted in accordance with the Swiss Ordinance relating to Good Laboratory Practice (GLP), adopted on May 18, 2005 (RS 813.112.1). This Ordinance is based on the OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted on November 26, 1997 by decision of the OECD Council (C(97)186/Final).
Data generation, documentation, and reporting are performed following established SOPs and quality processes intended to ensure traceability, integrity, and compliance with applicable GLP principles. The suitability of generated data for regulatory use is assessed on a study-by-study basis in alignment with the applicable regulatory context and client requirements.
Good Clinical Practice - GCP
The quality standard of Good Clinical Practice (GCP) has been implemented at IBR Inc. since 2012. Clinical bioanalytical activities are conducted in alignment with applicable GCP principles as defined in ICH E6 (R3), including risk-based quality management, data integrity, and appropriate oversight of critical trial processes.
IBR Inc.’s GCP framework is further informed by relevant European guidance, including the EMA Reflection Paper on GCP compliance in clinical trials (EMA/INS/GCP/532137/2010, effective February 28, 2012), as applicable to laboratory activities supporting clinical studies.
The analysis of clinical trial samples is performed using appropriately qualified and, where required, validated bioanalytical methods with predefined acceptance criteria. Method performance characteristics, documentation, and data handling procedures are defined to ensure reliability, traceability, and suitability of results for their intended clinical and regulatory use. The regulatory acceptability of analytical data is assessed on a study-specific basis in accordance with sponsor requirements and the applicable regulatory context.
Good Manufacturing Practice - GMP
IBR Inc. has been GMP compliant since 2019 following inspection and certification by Swissmedic for defined laboratory activities, including physicochemical analyses, bioanalytical testing, and microbiological analyses, within the approved scope.
IBR Inc.’s quality system is aligned with the Swiss GMP requirements and the applicable European Union GMP framework as described in EudraLex, Volume 4, Good Manufacturing Practice Guidelines. This includes, where relevant to laboratory operations, current expectations related to quality systems, documentation, qualification and validation, computerized systems, and data integrity. The GMP framework is further aligned, as applicable, with U.S. FDA current Good Manufacturing Practice (cGMP) requirements for human pharmaceuticals (21 CFR Parts 210 and 211).
An independent in-house Quality Assurance function provides oversight of the GMP quality system. Regulatory responsibility for GMP-relevant activities is ensured by the designated Responsible Person in accordance with Swiss requirements (Fachtechnisch verantwortliche Person, FvP). These functions ensure that GMP-relevant activities are conducted in compliance with approved procedures, applicable regulations, and the defined scope of certification.
IBR Inc. operates an integrated quality system ensuring the controlled conduct of laboratory activities from study planning through execution and reporting, in alignment with applicable GLP, GCP, and GMP requirements. The system is designed to support data integrity, traceability, and appropriate quality oversight.
IBR Inc. has demonstrated proficiency in assay development and validation. Where applicable, activities are performed in accordance with recognized regulatory and scientific principles, including ICH Q2 (R1), relevant USP chapters (<1032>, <1033>, <1034>), applicable elements of ICH M10 for bioanalytical methods, and GCP principles as defined in ICH E6 (R3). Immunogenicity and anti-drug antibody (ADA) assessments are informed by relevant EMA and FDA guidance, as appropriate.
Procedures and documents are managed throughout their lifecycle to ensure continuous alignment with regulatory expectations and client requirements. The quality system is routinely verified through internal inspections, client audits conducted by sponsors from Europe, the United States, and the Middle East, and inspections by regulatory authorities. Robust sample management practices form an integral part of IBR Inc.’s GxP-compliant laboratory operations.
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