news
More than half of EU clinical trials do not comply with rules
Researchers from the University of Oxford have identified that only 49.5 percent of clinical trials correctly report their results on time...
List view / Grid view
QA/QC
news
Driving real-time productivity insights with connected laboratory automation
Tecan is offering its customers unprecedented insight into how their Fluent® and Freedom EVO® liquid handing platforms are being used, thanks to its Introspect™ and Common Notification System (Tecan CNS™) software tools...
article
Quality Assurance / Pharmaceutical Quality Systems in manufacturing medicinal products
Quality Assurance (QA) covers all aspects that could have an impact on the quality of prescribed pharmaceutical products. This article focuses on some of the Pharmaceutical Quality Systems in relation to QA of manufactured medicines.
article
How the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes
This article explores how the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes.
article
Specifications and method/process capability: two sides of the same coin
Specifications are defined as “a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described”.1
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Spotlight on… Manufacturing
In this Spotlight on Manufacturing, ACG explains how it meets clients’ changing needs and identifies emerging market trends...
whitepaper
Scientific Poster: Quantitation of monoclonal antibody infliximab in human plasma by LC-MS/MS using Fab-selective limited proteolysis nSMOL technology
Infliximab, commercially known as Remicade, is a chimeric IgG1 kappa monoclonal antibody (mAb), that targets tumor necrosis factor-alpha (TNF)....
article
Avoiding environmental monitoring ‘false negatives’: overcoming disinfectant residues with culture media neutralisers
Even with the rise of rapid microbiological methods, most environmental monitoring applications are undertaken using culture media, with many alternative methods also being growth-based. This makes the selection, control and release of culture media an area of great importance, given that the quality of the culture media underpins the environmental…
news
Improving drug safety in East Africa is aim of new project
A new project led by the Karolinska Institutet in Sweden aims to improve the standards of drug safety in East Africa...
article
Software tools that enable confident GC-MS analysis of extractables in pharmaceutical products
Pharmaceutical products come into contact with a wide range of polymeric materials on their journey from the production line to patients. Plastic and rubber contact surfaces are present at almost every stage of a product’s lifecycle: they’re present in single-use systems, such as filters and tubing employed in manufacturing processes;…
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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.
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...
article
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…
