EMA announces launch of collaborative pilot scheme to inspect manufacturers
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
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The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
The UK MHRA has issued a recall of two ranitidine products from Medley Pharma as a precautionary measure due to possible contamination.
Several organisations have developed guidelines that specifically address genotoxic impurities in pharmaceutical products. Here, Dr Sol Bobst and Gowri Sukumar discuss the regulatory landscape, testing requirements and calculation methods for occupational exposure limits.
Clinical microbiologists have started using new, non-conventional methods to study the microbiology of the human gut. In this article, Jeanne Moldenhauer discusses the intricacies of culturomic and metagenomic studies and how this can advance current research.
Since it was discovered in the 1920s, Raman spectroscopy has been used in pharmaceutical research as a non‐invasive way to provide chemical and structural information in situ, without any staining or complicated sample preparation. Nikki Withers spoke to Professor Kishan Dholakia to hear more about its use in industry and…
Lumasiran, an investigational drug to treat primary hyperoxaluria type 1, has met its endpoints in clinical trials.
Industry experts share their latest research and developments in pharma.
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
Raman microscopy is well suited to pharmaceutical studies, including the analysis of drug delivery systems and their performance.
Sustainable reagents based on recombinant horseshoe crab Factor C (rFC) provides advances in endotoxin testing.
Over the last decade, Transmission Raman spectroscopy (TRS) has been increasingly implemented in pharmaceutical laboratories as a highspeed, accurate, quantitative analysis solution.
This in-depth focus includes features that examine how microbiologists can advance their methods of study, discuss the regulatory guidelines regarding genotoxic impurities and explore Raman spectroscopy as a non-invasive analysis technique.
A new pharmacovigilance document from the European Medicines Agency shows that the medicine safety system in the EU is effective.
ICH M9 biopharmaceutics classification system-based biowaivers1 is currently at step 2b and feedback from interested parties is being evaluated.2 This guideline should reach the implementation stage (step 4) during 2020. However, industry still has concerns relating to several key areas of the guidance. Here, Dave Elder summarises these ICH M9…
In this issue are articles that explore the impact of M&As within the life science industry, discuss the security trends for medicinal packaging and investigate genotoxic impurities within pharmaceutical products. Also included are features on nanobot drug delivery systems and Raman as an effective analytical approach.