news
Blister material as a source of nitrosamine impurities
Study reveals lidding foil with nitrocellulose primer is a potential source of nitrosamine impurities for pharmaceuticals, especially when using plate sealing equipment.
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QA/QC
article
Progress in the implementation of biofluorescent particle counters
Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
article
A strategic approach to optimisations of testing bacterial endotoxins
Given industry's recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise. They also explore some of the short-term…
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European Pharmaceutical Review Issue 4 2022
In EPR Issue 4, experts discuss implementing a global strategy to improve the sustainability of endotoxin testing, how to accelerate timelines for manufacture of multi-specific antibodies and the potential of oncolytic viruses as a therapy for glioblastoma. Also featured: progress towards smart vaccine manufacturing, an update on edible anticounterfeiting technology,…
news
Common pharma compliance concerns cited by FDA warning letters
A review of the last decade of FDA warning letters finds quality control operations, manufacturing process validation, and data record and integrity are the key points of scrutiny.
news
Does terminal sterilisation affect the quality of ophthalmic APIs?
EPR summarises research into the impact of gamma irradiation and ethylene oxide sterilisation treatments on European Pharmacopoeial compliance of common ophthalmic APIs.
whitepaper
Whitepaper: A beginner’s guide to AI driven pharmacovigilance platform
In this whitepaper, authors have shared their experience on AI-driven technology adoption in pharmacovigilance.
video
On-demand webinar: The advantages of cartridge technology
Why do pharmaceutical manufacturers still believe older methods are reliable for quality testing when there’s superior technology available on the market?
news
Pharmacopoeias to further support vaccine development and supply
US and European Pharmacopoeias announce new activities to help promote vaccine development, manufacturing, quality and supply.
webinar
Enhancing the scientific experience using laboratory software
28 July 2022 | By Thermo Fisher Scientific
Watch this webinar as we discuss how to successfully leverage software capabilities to enhance the scientific experience for your laboratory and laboratory personnel.
news
NA to NAM ratio as a biomarker for cell therapy sterility
Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
whitepaper
Whitepaper: Analytical methods for COVID-19 vaccine production
This whitepaper shares how analytical solutions from METTLER TOLEDO can be used to characterise COVID-19 vaccines.
video
Video: Free 10-minute pharma data integrity training
Ex-MHRA inspector and NSF expert, Rachel Carmichael, takes a high-level look at why Data Integrity matters in this online introduction training.
![Photo of affected lot - PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100 mL Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Propofol-recall-300x278.jpg)
![Photo of affected lot - PROPOFOL Injectable Emulsion, USP (contains benzyl alcohol) 100 mL Single Patient Use, Glass Fliptop Vial. Lot DX9067 [Credit: Pfizer].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Propofol-recall-e1657792683882.jpg)
news
Hospira recalls lot of Propofol Injectable Emulsion
The voluntary US-wide recall of Lot DX9067 of Propofol Injectable Emulsion, USP is due to the possible presence of visible particulate with potentially harmful effects.
news
Microbial risks presented by aging facilities
Here, EPR summarises the microbial contamination concerns that may arise from aging facilities presented in an article by Tim Sandle.
