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The Directive on Falsified Medicines (FMD, or Directive 2011/62/EU amending Directive 2001/83/EC) and its supplementing Delegated Regulation (DR 2016/161) aim to improve patient safety by preventing falsified medicines from entering the legal supply chain...
Plastic materials used in pharmaceutical packaging can interact with the packaged dosage form, causing leachables to accumulate...
Guardino (2005) identified the first rapid microbiological method as a rapid plate count technique. This method was developed by Professor Frost...
Gas chromatography (GC) predates the more commonly utilised high performance liquid chromatography (HPLC). However, GC continues to enjoy some important niche applications in modern pharmaceutical analysis, such as the analysis of residual solvents or volatile organic compounds (VOCs)...
Over 12 months ago, the European Union delegated regulation that supplements the Falsified Medicines Directive (FMD) was published in the Official Journal of the European Union, starting the countdown to the deadline of 9 February 2019, when most EU member-states, and three non-members currently, are expected to have implemented all…
Water is widely used in pharmaceutical manufacturing – either as a raw material, as an ingredient, or as a final product. Water is also used for rinsing equipment or for the preparation of disinfectants and detergents...
Biological products, usually referred to as biologics, constitute a significant segment of pharmaceuticals in development. Biologics include therapeutic proteins, antibody drugs, antibody-drug conjugates (ADCs), vaccines, carbohydrates drugs, blood and tissue-derived pharmaceuticals, gene therapies, even live cells and tissues...
Presented here are recommendations for performing an endotoxin masking hold-time study. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have requested hold-time studies to determine the presence of what has been called ‘low endotoxin recovery’ (LER) for submission with biologic licence applications (BLA)...
Read the free-to-view digital version of the latest issue of European Pharmaceutical Review...
In this Mass Spectrometry In-Depth Focus: Mass spectrometry in the development of protein biologics; and GC-MS applications in pharmaceuticals analysis...
In this Microbiology In-Depth Focus: Endotoxin masking hold-time study performance parameters; Microbiological monitoring pharmaceutical water systems; The rush to rapid microbiological methods - or not; and an expert view with Charles River Laboratories...
Biotech and pharmaceutical firms hold vast amounts of valuable data and information making them prime targets for cyber-attacks – so how are they protecting themselves?
Single-use systems have become an important tool in the development and scale up of biotechnology processes. Single-use systems save space, increase flexibility in scale and space planning and, to a large extent, eliminate cleaning costs in development and change over.
FMD and supply chain security; Strategic aspects of change control for pharmaceutical packaging systems; and does the Falsified Medicines Directive lead to a European pack coding guideline?
