Quality Assurance (GLP/GCP)

Quality Assurance in Bioanalysis: Ensuring Excellence for Our Clients
At our bioanalytical contract research organization (CRO), quality assurance (QA) is at the heart of everything we do. Our dedicated QA team ensures that every step of the bioanalytical process, from method development and validation to sample analysis and data reporting, meets the highest standards of data integrity, accuracy, precision, and reliability.

Why Quality Assurance Matters
Quality assurance is essential for generating bioanalytical data that can be trusted by regulatory authorities and other stakeholders. Our QA team ensures compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) guidelines, as well as other relevant regulatory requirements. This involves regular audits, thorough reviews of study plans and reports, and continuous training for our personnel.

Benefits for Our Clients

1. Reliable Data: Our robust QA system ensures that the data we generate is accurate and reliable, providing our clients with the confidence to make informed decisions about the safety and efficacy of new drugs.
2. Minimized Risk: By standardizing and controlling all procedures, we minimize the risk of errors and inconsistencies, reducing the likelihood of costly delays and rework.
3. Enhanced Reputation: Our commitment to quality and compliance enhances our reputation and builds trust with our clients. This not only attracts more clients but also secures long-term partnerships, leading to increased business opportunities and growth.

In summary, our quality assurance practices in bioanalysis are designed to ensure the highest level of data integrity and reliability. For our clients, this means dependable results, reduced risks, and a trusted partnership with a CRO that prioritizes excellence in every aspect of bioanalysis.

In order to garantee the best quality performance to our customers, Swiss BioQuant practices comprehensive and systematic quality management. Quality as a significant attribute of performance is the result of careful planning and subject to constant controls by our internal quality assurance group.

Regulatory Compliance

The Quality assurance unit performs regular inspections for all GLP and/or GCP compliant studies and facility inspections are conducted several times a year. 

Swiss BioQuant was successfully inspected by the Swiss authorities (Swissmedic) in July 2008 stating the GLP compliance of the test facility according to the Swiss Ordinance relating to Good Laboratory Practice, 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].

Swissmedic GLP Certificate 2024

For the bioanalytical part of a clinical study the principles of GCP are followed as described in the EMA Reflection paper.

EMA reflection paper for bioanalytical laboratories

ICH M10 bioanalytical method validation