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Data integrity and compliance with drug current good manufacturing practices
The FDA has provided guidance on data integrity and compliance; two areas extremely important for pharmaceutical businesses and manufacturers to adhere to...
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Manufacturing
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Application Note: Microbiological considerations in cleanroom validation
Contamination, microbiological or otherwise, is a key safety concern in the development and manufacture of all pharmaceuticals and medical devices.
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Application Note: Focus on the fundamentals
Fundamentals. The drab cousins of the headline grabbers like AI or Pharma 4.0. But focusing on them can be the investment that offers the most long-term rewards for companies in terms of risk mitigation, cost reduction and improved overall agility. In pharmaceutical packaging and labelling, the key fundamental is the…
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Application Note: Quality manufacturing solution – interfacing with third-party systems
Most organisations that are looking to implement a new LIMS or replace an aging one have a significant investment in a number of information systems.
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Whitepaper: Big Data in pharmaceuticals – big opportunities or big challenges or both?
Big data covers every facet of our working life. Every aspect of pharmaceutical research and development involves the generation of huge quantities of data, with the expectation that we can turn this information rapidly into useful knowledge, which in turn can be used to make ‘data-driven’ decisions to better understand…
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Application Note: Real time, low flow, pharmaceutical soil cleanability profiling with TOC and conductivity
Designing a robust cleaning process for pharmaceutical drug manufacturing is critical to successful cleaning validation and verification.
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Application Note: Representative sampling of solids and turbid media in process raman spectroscopy
Raman spectroscopy is an analysis technique that provides a “molecular fingerprint” of the sample, enabling analysis of chemical composition and molecular structure without sample preparation. As a measurement technique, Raman imparts many benefits in applications from laboratory discoveries to feedback-control in manufacturing.
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Sprayable gel with CD47 blockers could be the future of drug delivery for cancer
A sprayable gel containing calcium carbonate nanoparticles with antibodies targeted to block CD47, could be the future of drug delivery for cancer...
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Licences for manufacturers and wholesalers of medicines and ingredients
Updated public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended...
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Meet Danilo Neri, PQE Group Vice President
Find out more about PQE Group services from our Vice President and Partner Danilo Neri at last PharmaLab 2018 in Dusseldorf.
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FDA grants frontotemporal dementia drug Orphan-Drug Designation
A dementia drug has been given Orphan Drug Designation by the FDA, meaning this special status will qualify sponsors of the drug for development incentives...
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CPhI report forecasts India to have strongest global growth in 2019
CPhI & P-MEC India opens as report ranks India the world’s fastest improving pharma market and first for ‘growth potential’ for 2019...
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Thermo Scientific TruScan RM with TruTools onboard chemometrics
TruScan RM with TruTools extends raw material identification to complex analysis problems such as quantification of components and final product identification.
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Thermo Scientific microPHAZIR RX handheld NIR analyser
microPHAZIR RX handheld analyzer is used by pharmaceutical manufacturers for GMP compliant incoming raw material identification, quality control and assurance, and at-line PAT.
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Protection against yellow fever provided by fractional-dose vaccination
Researchers at Leiden University Medical Center have identified how fractional-dose yellow fever vaccinations protect against the condition for ten years...
