As of October 2020, EMA and the national competent authorities are asking marketing authorisation holders for metformin-containing medicines to test their medicines before releasing them onto the market. The risk evaluation for chemical medicines should be completed at the latest by 31 March 2021 and 1 July 2021 for biological medicines.
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
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
