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18 July 2019 | By Victoria Rees (European Pharmaceutical Review)
An Indian pharmaceutical company was planning to shred quality control records ahead of an FDA inspection, found officials.
16 July 2019 | By Victoria Rees (European Pharmaceutical Review)
Altaire Pharmaceuticals has announced a recall of 31 products due to a lack of sterility assurance from their manufacturing facility.
15 July 2019 | By Victoria Rees (European Pharmaceutical Review)
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.
12 July 2019 | By Victoria Rees (European Pharmaceutical Review)
A pharmaceutical manufacturing site in New Jersey receives FDA warning letter for failing to thoroughly investigate quality problems and data integrity issues.
12 July 2019 | By Victoria Rees (European Pharmaceutical Review)
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
4 July 2019 | By Victoria Rees (European Pharmaceutical Review)
New guidance drafts have been announced by the FDA to improve patients understanding and keep information consistent.
3 July 2019 | By Victoria Rees (European Pharmaceutical Review)
Three API re-packers who failed to meet current good manufacturing practice requirements have received warning letters from the FDA.
3 July 2019 | By Victoria Rees (European Pharmaceutical Review)
Substandard and counterfeit drugs can negatively impact the pharmaceutical industry and patients. Here, we investigate counterfeits in south-east Asia and possible solutions.
2 July 2019 | By Merck
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.
1 July 2019 | By Zafar Iqbal
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.
1 July 2019 | By Jeanne Moldenhauer
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.
1 July 2019 | By Vanda Dolabela de Magalhães
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.
1 July 2019 | By Jessica Clifton
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.
1 July 2019 | By Victoria Rees (European Pharmaceutical Review)
The ABPI has reported findings from its transparency initiative, Disclosure UK, stating that R&D investment grew significantly from 2017 to 2018.
1 July 2019 | By Neal Singh
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…
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