In this case study, the principles of quality risk management were applied to review sampling
points and monitoring frequencies in the hormonal tableting unit of a formulation …

Environmental monitoring programs are essential for pharmaceutical facilities in order to
assess the level of environmental control. For biotechnology facilities there is little advice as …

To determine the relationship between the sampling time of the environmental monitoring,
ie, viable counts, in aseptic filling areas and the microbial count and frequency of alerts for …

In the present work we compared different calculation approaches for their ability to
accurately define microbiological control levels based on historical data. To that end, real …

In order to guarantee the consistently high quality of medical products for human use, it is
absolutely necessary that flawless hygiene conditions are maintained by the strict …

Purpose Little attention has generally been given to non-sterile pharmaceutical
manufacturing, because these products represent less microbial contamination risks …

Cleaning validation in the manufacture of pharmaceutical forms is a critical step in
implementing the rules of Good Manufacturing Practice (GMP). This process is very …

Purpose: Microbiological environmental monitoring of air quality is a key tool to determine
the appropriateness of manufacturing area in clean rooms for microbiologically safe …

In order to estimate the data integrity risk of microbiological tests and then adjusting the level
of mitigation actions based on the risk intensity, risk matrix tools may be used. In …

Cleaning manufacturing equipment to prevent cross contamination of pharmaceutical
products is a fundamental aspect of GMPs. Validation of cleaning processes has been …