Statement from the FDA on NDMA found in drugs outside the US
The FDA has released a statement on the investigations into the presence of nitrosamines in some drugs; highlighting that there are currently no recalls of metformin within the US.
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The FDA has released a statement on the investigations into the presence of nitrosamines in some drugs; highlighting that there are currently no recalls of metformin within the US.
Loss of manufacturing capability as a result of regulatory non-compliance can have a devastating impact on biopharma or medical device manufacturers. In this article, Jenny Yu shares real-life examples from the industry and highlights the downstream effects of these business interruptions.
29 October 2019 | By Thermo Fisher Scientific
This webinar explored the use of the Thermo Scientific™ handheld Raman analyser TruScan™ RM with TruTools™ on-board chemometrics to verify the identity of challenging raw materials.
A new report has said the osteoarthritis therapeutics market is estimated to grow due to rapid increase in the geriatric and obese population.
19 September 2019 | By SUEZ
This webinar will present how to easily evaluate "fitness for purpose" of a TOC instrument for compendial water and cleaning validation applications based on USP and ICH Q2(R1).
An Indian pharmaceutical company was planning to shred quality control records ahead of an FDA inspection, found officials.
Substandard and counterfeit drugs can negatively impact the pharmaceutical industry and patients. Here, we investigate counterfeits in south-east Asia and possible solutions.
In this webinar, we will introduce you to the microbial environmental monitoring in production isolators. You will learn how to be compliant and ease your workflow.
Microbial risk in pharmaceutical process is not limited to living microorganisms and intact microbial cells.
It is a requirement of both US and EU regulations that pharmaceutical packaging operations demonstrate integrity. As technology-based solutions remain somewhat of an unknown quantity, this whitepaper tests the hypothesis that Sepha’s VisionScan test method is considered non destructive.
The global pharmaceutical intermediates market is likely to see year-on-year growth in 2019, by an estimated 3.6 percent rate.
Lubricants have a far more wide-reaching impact on the characteristics of the finished tablet than merely easing their means of production. A study was carried out to investigate precisely what those effects were.
14 May 2019 | By Abbott Informatics
Understand the role of data integrity in current good manufacturing practice for drugs as required in 21 CFR parts 210, 211, and 212.
The US Food and Drug Administration (FDA) has approved new treatments for heart disease caused by ATTR-CM in adults.
Single-use GORE LYOGUARD freeze-drying trays help reduce operating costs by minimising time spent cleaning freezers and by eliminating tray cleaning.