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QA/QC In-Depth Focus 2018
In this issue: Anastasia Petropoulu focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines, and Dave Elder looks at method/process capability in terms of QA/QC.
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QA/QC
whitepaper
Application Note: Gas safety in the laboratory
Modern laboratories use a number of gases as part of their daily operations. This application note details two of the most common methods of laboratory gas supply, and their associated safety risks and benefits...
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Environmental Monitoring In-Depth Focus 2018
In this issue: the importance of culture media selection, control and realease, how the new draft of Annex 1, Manufacture of Sterile Medicinal Products is impacting environmental monitoring programmes, and software tools that enable confident GC-MS analysis of extractables in pharmaceutical products.
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Issue 4, 2018
A US perspective on how pharma companies are preparing for Brexit, overcoming disinfectant residues with culture media neutralisers, unlocking the potential of new technology in biopharma, and much more in this issue of European Pharmaceutical Review.
webinar
Advances in automated performance verification for UV/VIS spectrophotometers
22 August 2018 | By Mettler-Toledo
Regulated environments require performance verification (qualification) of UV/VIS spectrophotometers on a regular basis. Instrument performance is the main factor directly affecting the accuracy and repeatability of measurements. Hence, it is important that this is regularly monitored and that documentary evidence is provided. Optical performance verification is conducted to the widely…
whitepaper
Whitepaper: Why should you care about Burkholderia cepacia?
The Burkholderia cepacia complex (BCC) species are a group of gram-negative, rod-shaped bacteria that have been shown in recent years to be of concern for patients, and thus for manufacturers of drugs and products that contribute to patient health...
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Peak Scientific reveals dedicated gas solution for MP-AES
Peak Scientific, the global leader in gas generation for analytical laboratories, has today introduced its latest nitrogen gas solution to the market. HALO, a nitrogen gas generator specifically designed for MP-AES, is an evolution of Peak’s successful Genius 3055 nitrogen generator...
webinar
Understanding current CFR 21.11 and data integrity requirements
8 August 2018 | By SUEZ
The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…
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Impurity in valsartan leads to voluntary recall
Some drugs with active ingredient valsartan have been recalled due to presence of impurity NMDA...
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The Natural History Museum uses Linkam temperature- controlled microscopy to study inclusions in mineral deposits
Market leaders in temperature-controlled microscopy and leaders in sample characterisation solutions, Linkam Scientific Instruments, reports on the research of Dr Jamie Wilkinson of the Natural History Museum in London where he uses temperature-controlled microscopy to characterise mineral deposits...
webinar
Quality assessment of biologics: higher order structure analysis using NMR
27 July 2018 | By Bruker
The webinar describes how 2D NMR can offer protein biochemists unprecedented analytical precision. By assigning just one spectrum, users can obtain a unique fingerprint of a protein at an atomistic resolution. This non-destructive technique can also be combined with other complimentary techniques to gain even further insights into sample quality.…
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RWS Life Sciences welcomes new VP of Quality
RWS Life Sciences welcomes Clarice Streets, ASQ, CMQ, OE, as Vice President, Global Quality and Process, in charge of the strategic direction and implementation of its Quality system, underlying organisational processes, and change management...
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ProCellicssup™ in-line and real-time bioprocess raman analyser multi-channel unit
ProCellics™, first in-line and real-time bioprocess raman analyser, is a RESOLUTION Spectra Systems product. It offers a GMP user-friendly and easily deployed Process Analytical Technology (PAT) solution...
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Direct anticoagulants associated with increased risk of bleeding
Results of a study suggest the need for caution in the prescription of direct oral anticoagulants for patients with chronic kidney disease, due to the risk of bleeding...
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The future of water is clear – MECO ushers in a more efficient and environmentally friendly future for water purification
Taking advantage of technology developed in recent years, MECO announces smartANALYTICS® as a means of connecting its water purification machines and systems with big data analytics and in house expertise...
