In relation to a growth in reported incidents of fungal contamination of pharmaceutical
products, there has been a developing interest by US and UK regulators concerning the risk …

Introduction Quality and safety of a cell product, essential to guarantee the health of patients,
depends on many factors including an appropriate environmental monitoring of the …

Abstract The Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and
Cell-Based Drug Discovery (SCB) supports the development and commercialization of …

To maintain asepsis in production environments, contamination must be constantly
controlled. To this end, microbiological monitoring is constantly used with the objective of …

Objetivos: Determinar la calidad microbiológica de una muestra de productos naturales
procesados de uso medicinal de libre comercio en Quito, Ecuador. Materiales y métodos: 83 …

This review article discusses several technologies using the power of genetic analysis that
were used to rapidly detect microbial contamination, provide a more accurate identification …

Objectives: To determine the microbiological quality of samples from processed natural
products used for medicinal purposes and marketed in Quito, Ecuador. Materials and …

Environmental monitoring in pharmaceutical industry was studied by using settle plate, air
sampling, surface monitoring and personnel monitoring. These methods are commonly …

Several recently published articles have promoted the process analytical technology (PAT)
initiative as the path to the real-time release (RTR) of finished product. Many strong …

The accurate and consistent microbial monitoring of controlled rooms as a measure of
quality control is an important measure in the manufacture of sterile and nonsterile …