Category: Pharma | Tentamus

COVID-19: FDA introduces new risk assessment system for inspections

The U.S. Food & Drug Administration (FDA) is preparing to resume domestic inspections with a new risk assessment system. Due to the corona pandemic, restrictions have been in place since March. In order to continue to bring safe products onto the market or to monitor them on a risk-based and qualitative basis, guidelines and processes

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COVID-19: How Robust is your Pharmaceutical Supply Chain?

2020 will be remembered for a long time as a time that changed our personal and professional lives. From R&D through manufacturing to distribution, the pandemic is impacting the pharmaceutical sector. The industry has been invigorated in recent months but is also being compromised, most notably through supply chain disruption. Even as in-country restrictions are

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Renolab is extending its certification

In vitro pharmacodynamics (PD) for human use drugs with anti-infectious activity Starting from 2019, the microbiology department at Renolab is extending its certification, thus continuing the providing of pharmacodynamics (PD) services based on the relationship between the properties of new drugs and bactericidal, fungicidal and virucidal effects. The tests will be conducted following the

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Microbiological Services at VelaLabs Facilities fully operational in July

Vienna, May 2020: Last year in June, VelaLabs, part of the Tentamus Pharma division, acquired the pharmaceutical test laboratory “Laboratorium für Betriebshygiene GmbH” (LABH). LABH is focusing on microbiological services such as sterility testing in accordance with Ph. Eur. requirements as well as environmental control and germ identification. Consulting in these areas is also part

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Changes in the (pharma) world during the COVID-19 pandemic

The pharmaceutical industry is subject to constant change. In the last decade, the production of raw materials and active ingredients in particular has increasingly been relocated to countries where production can be carried out in a more cost-effective manner. Outsourcing to external contract manufacturers, so-called “Contract Manufacturing Organizations” (CMO), has become increasingly popular. However, the

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New limits for nitrosamines from 2021

Nitrosamines are found in cosmetics, pesticides, tobacco products, and most rubber products. These chemical compounds are formed when nitrites and amines come into contact with acid (e.g. stomach acid) or during production of e.g. pharmaceuticals. Another possibility is the release from the breakdown of specific organic substances. High temperatures encourage the growth of nitrosamines (e.g.

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Product analytics & market release of hydroxy-chloroquine & chloroquine

Speculation is ongoing that a decade-old malaria drug may be one of the key medications slowing down the spread of the novel coronavirus (COVID-19). This dedicated drug is comprised of the chemical chloroquine. Although these chemicals are not legislatively approved to treat COVID-19, an off-label use is in discussion. Recent studies suggest that chloroquine is

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Medical Device Regulation: Transitioning from MDD to MDR

On 26 May, 2021, the Medical Device Directive (MDD) will be replaced by the new Medical Device Regulation (MDR). MDR is designed to be an improved version of MDD, with the major difference being that MDR influences and provides effectiveness to all EU member states. This allows MDR to provide a regulation which is consistent

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Drug-NDMA-impurities-Ranitidine-analysis

Analysis of N-Nitrosodimethylamine (NDMA) – Impurities in Ranitidine

In September 2019, the U.S. Food and Drug Administration (FDA) published a statement of NDMA found in samples of ranitidine, a drug used to treat peptic ulcer disease, gastroesophageal reflux disease and Zollinger-Ellison syndrome. NDMA is a substance from the class of compounds known as Nitrosamines and is well documented to be an environmental contaminant

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Tentamus Pharma Group at CPhI worldwide 2019

The Tentamus Pharma Group bundles all competences in the field of drug and medical device testing and is made up of class leading independent laboratories, providing high quality service and support to our clients worldwide. Our client base ranges from small start-up companies to multi-national corporations, encompassing a comprehensive and diverse portfolio of services to

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