Risks are increasingly regulated by international standards, and scientists play a key role in
standardisation. This fascinating book exposes the action of'invisible colleges' of scientists …

Abstract Objective To apply the Hazard Analysis and Critical Control Points method to the
preparation of anti-cancer drugs. To identify critical control points in our cancer …

Both pervasive and ubiquitous, computerized systems are now an integral component of
every corporate strategy in pharmaceutical and healthcare companies. However, when …

Effective quality risk management can facilitate better and more informed decisions, provide
regulators with greater assurance of a company's ability to deal with potential risks and can …

Pharmaceutical sterilization is the process that effectively kills or removes all forms of
microorganisms including bacteria, spores, and fungi from pharmaceutical preparations …

Risk analysis is widely used in the pharmaceutical industry to manage production
processes, validation activities, training, and other activities. Several methods of risk …

In 2020 a new contamination control standard has been issued, specifically focusing on
biocontamination control, titled EN 17141: 2020 “Cleanrooms and associated controlled …

One key quality control parameter for biopharmaceutical products is the analysis of residual
cellular DNA. To determine small amounts of DNA (around 100 pg) that may be in a …

Some industries have adopted different types of systems to ensure quality. These include
failure mode effect analysis (FMEA), root cause analysis and hazard analysis critical control …

The purpose of microbiological environmental monitoring is to assess the cleanliness of
pharmaceutical (sterile and non-sterile) and medical device manufacturing environments …