news
FDA encourages appropriate prescribing of opioids
The FDA has updated its Opioid Analgesic REMS to ensure caregivers and patients use opioids effectively...
List view / Grid view
QA/QC
news
SPC manufacturing waiver is good news for Europe
An SPC manufacturing waiver should be extremely beneficial for Europe and will increase net sales of the EU pharmaceutical industry...
news
FDA steps up action to ensure quality of compound drugs
The FDA is seeking closer collaboration with state authorities to ensure the quality of compounded drugs and the public’s access to them...
news
Is cancer fundraising fuelling deceit?
Researchers questioned whether cancer crowdfunding elicits deception, especially when offering patients treatments with no scientific backing...
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...
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...
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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.
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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.
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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)....
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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...
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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.
