A GLP certification (Good Laboratory Practice) is essential in the testing of substances in drug development. It confirms compliance with a quality management system that includes responsibilities, proceedures and framework conditions for the testing of samples from non-clinical studies. Non-clinical trials take place in the early stages of drug development.
Clients working with a GLP contract laboratory such as VelaLabs can rely on proceedures in accordance with GLP to maintain high standards.
Klaus Hajszan, Head of Quality and Test Site Manager, about this important step: “We have been GLP certified in 2020 for the first time and since then have continuously improved and strengthened our testing processes to ensure safety and quality”.
The audit was done by BASG – Bundesamt für Sicherheit im Gesundheitswesen / Austrian Federal Office for Safety in Health Care within the scope of the national GLP monitoring program as provided by the Ordinance on Good Laboratory Practice, Federal Gazette II, No 450/2006.
About VelaLabs:
VelaLabs (founded in 2006) is a global, GLP/GMP certified and GC(L)P-compliant contract laboratory that provides analytical characterization services for pharmaceuticals, including proteins, biosimilars, hormones, monoclonal antibodies and peptides. With broad expertise in customer-specific analytical method development and analysis and a highly motivated team, VelaLabs supports its customers from research to preclinical & clinical phases to product commercialization and market release in Europe.
Since 2021, VelaLabs, equipped with a cleanroom newly built in 2020, has been offering the entire spectrum of sterility and microbiological services with a focus on the pharmaceutical sector. VelaLabs, based in Vienna (Austria), has been part of the Tentamus Group since 2016.
Further information: www.vela-labs.at.
Tentamus Group GmbH was founded in 2011. Tentamus is a global product and safety group with a core presence in Europe, UK, Israel, China, Japan, India and the USA. Accredited and licensed Tentamus Group tests, audits and consults on all products involving the human body (food & feed, pharmaceuticals & medical, agrosciences, cosmetics, agriculture & environment and nutraceutical & supplements). Tentamus Group is represented in over 85 locations worldwide. More than 3,500 highly-trained staff members work in over 3 million square feet of laboratory and office spaces. For further information please visit www.tentamus.com.
Tentamus Group
An der Industriebahn 5
13088 Berlin, Germany
www.tentamus.com
Tentamus Group GmbH
An der Industriebahn 26
13088 Berlin
Telefon: +49 (30) 206038-230
Telefax: +49 (30) 206038-190
http://www.tentamus.com
Marketing und PR VelaLabs GmbH
Telefon: +43 699 1314 3195
E-Mail: u.jahn@vela-labs.at