whitepaper
Whitepaper: Recent advances in pharmaceutical regulations for viable environmental monitoring
Regulations provide specifications for the selection of an effective air monitoring strategy, both directly and indirectly.
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Climate change: how pharma will profit from a warming planet
Rising temperatures will likely accelerate the spread of vector-borne diseases, resulting in an increased demand for vaccines. European Pharmaceutical Review investigates a Morgan Stanley report on the pharmaceutical beneficiaries of climate change.
news
Tecan Synergence™ offers comprehensive approach to OEM system development
Tecan Partnering has consolidated its extensive OEM system development services for life sciences and IVD instruments to create Tecan Synergence™.
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Surge in negative verifications of saleable returns could cost pharma industry billions
The pharmaceutical industry is set to face some major changes in the near future, to improve the quality of returned drugs and medications.
news
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.
news
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.
news
Two lots of Kogenate® recalled due to mislabelling
Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.
news
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.
news
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.
news
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.
news
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.
