If a risk is identified for an active substance, marketing authorisation holders should proceed with confirmatory testing of the finished products identified to be at risk of N-nitrosamine formation. Precautionary testing to ensure patient safety are required for special drug products while the investigation is still ongoing.
The GMP-analytics experts at DSI-pharm support marketing authorisation holders to be in line with the requirements. A tailored solution is needed to overcome the hurdle of matrix effects and the low limit of quantifications.
“Our lab is capable to perform LC-MS or GC-MS depending on the matrix. Both methods are validated and can easily be adapted to all products. If necessary a product-specific full-validation according ICH-guidelines is performed. This is how we ensure the quality of your product!” explains Serap Acikgöz, Managing Director at DSI-pharm.
About DSI-pharm
DSI-pharm is a GMP certified laboratory which supports its clients in regards of pharmaceutical quality control – quickly, reliably and without complications. As a partner of pharmaceutical industry DSI-pharm shoulders responsibility for R&D projects and operates as an extension of our clients’ quality control (QC) workbench.
Please find further information at https://www.dsi-pharm.de
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 70 locations worldwide. More than 3,000 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 GmbH
An der Industriebahn 26
13088 Berlin
Telefon: +49 (30) 206038-230
Telefax: +49 (30) 206038-190
http://www.tentamus.com
General Manager Pharma; DSI-pharm
Telefon: +49 441 3613265 449
E-Mail: serap.acikgoez@tentamus.com