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Altaire issues sterile product voluntary recall
Altaire Pharmaceuticals has announced a recall of 31 products due to a lack of sterility assurance from their manufacturing facility.
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QA/QC
whitepaper
Application note: Rapid Analysis of Genotoxic Nitrosamines by HPLC-MS/MS
Genotoxic impurities (GTI’s) are intermediate, reactive products or degradants formed during drug synthesis, formulation or storage.
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Suspected counterfeit vaccines seized in Hong Kong
A medical centre in Hong Kong had 76 boxes of an HPV vaccine seized after a complaint from a patient who experienced adverse side effects.
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FDA sends warning letter to sterile injectables plant
A pharmaceutical manufacturing site in New Jersey receives FDA warning letter for failing to thoroughly investigate quality problems and data integrity issues.
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US and EU enter Mutual Recognition Agreement for drug manufacturing inspections
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
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Trend barometer Chemspec Europe 2019 closes with record in visitor numbers and exhibition space
The 34th and, so far, biggest edition of Chemspec Europe attracted a total of 4,295 trade visitors from 53 countries to the exhibition grounds of Messe Basel, Switzerland. From 26 to 27 June 2019, a total of 379 exhibitors from 27 countries presented their innovative substances on a record net…
whitepaper
Whitepaper: Impact of the Claristep® Filtration System on recovery and adsorption of various therapeutic proteins at low sample volumes
Comparison of the Sartorius Claristep Filtration System with standard sample preparation using syringe filters.
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FDA issues three warning letters to API re-packers
Three API re-packers who failed to meet current good manufacturing practice requirements have received warning letters from the FDA.
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The impact of counterfeit drugs in south and south-east Asia
Substandard and counterfeit drugs can negatively impact the pharmaceutical industry and patients. Here, we investigate counterfeits in south-east Asia and possible solutions.
whitepaper
Article: Tips & tricks: sensitivity gains in LC-MS
The prerequisite of any highly sensitive analysis via HPLC-MS (high performance liquid chromatography coupled to mass spectrometry) is the use of ultrapure solvents and reagents and careful handling of all associated materials, consumables, and systems.
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Raman spectroscopy of the amorphous phase from silicon to pharmaceutical drugs – a brief overview
Zafar Iqbal sheds light on how Raman spectroscopy is used to detect and understand the amorphous phase in a range of solids, providing examples of his own laboratory applications.
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Do viability methods detect all viable organisms?
Many bacterial species have been found to exist in a viable but non-culturable state. Jeanne Moldenhauer discusses this phenomenon and makes suggestions as to why we don’t often see an increase in viable cells when using viability-based methods.
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Assessing host cell protein contamination in biotechnological products
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
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Manufacturing medical devices to ISO 13485:2016
Continuous innovation is key to the advancement of medical device technology. To allow for innovation, whilst also assuring safety and effectiveness, global standards are required. This article provides information for companies manufacturing medical devices on the benefits of holding ISO 13485 certification and how to get certified.
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Brexit-tech: overcoming post‑Brexit challenges by driving operational and cost efficiencies
As 31 October draws closer, organisations across all sectors are putting contingency plans in place for whatever the impact of Brexit may be. However, for pharmaceutical organisations already operating in a heavily regulated, highly competitive landscape, the future looks a lot more uncertain than for most. Here, Neal Singh discusses…
