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PharmaLab 2019 – In times of changes
For the 7th time, PharmaLab, picks up the latest developments in regulations, quality control and assurance and in laboratory methods and systems.
List view / Grid view
QA/QC
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Roche confirms cyber-attack from Winnti malware
The pharmaceutical company Roche has affirmed that it was hit by a Winnti cyber-attack, thought to be supported by the Chinese government.
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Two lots of Kogenate® recalled due to mislabelling
Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.
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FDA approves nine generics for Lyrica drug
The FDA has announced that it has granted approval to the first nine generic drug applications for Pfizer’s Lyrica treatment.
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Complete response letter given to ALS treatment for API concern
The FDA has handed a CRL to Biohaven for its ALS treatment awaiting approval due to concerns regarding the medication’s API.
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Drug manufacturer planned to shred cGMP documents ahead of inspection
An Indian pharmaceutical company was planning to shred quality control records ahead of an FDA inspection, found officials.
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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.
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.
article
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.
