The Importance of Trending

What is Trending?

Trending, when used in a pharmaceutical microbiology laboratory, is the examination of long term data in order to examine if a controlled process is moving away from the state of control. Trending can also be used to determine the stability of a product’s efficacy by examining the results of testing over time. Stability trends are important to support expiry dates and storage conditions. Continue reading

Viable Environmental Monitoring

This was repurposed into a LinkedIn article as part of my Developing My Writing While Helping Others series.

What Is Viable Environmental Monitoring (VEM)?

Viable Environmental Monitoring (VEM) is the monitoring of factors within a production environment that may have an impact on the quality of goods produced within the environment. Typically this is any physical object than could support or introduce microbial contamination to a manufacturing environment: air, gases, surfaces (both on introduced objects and within the production room), liquids and people.  This discussion does not extend to Environmental Monitoring such as particle counting, temperature, pressure differentials, etc. Continue reading

What Makes An Objectionable Organism?

What is a specified organism?

A specified organism is one that according to the pharmacopeia, cannot be present in a sample (usually 10g). These microbes are specified either as they may be an indicator organism (a microbe where its presence may indicate a pathogenic microbe could be present) or they may actually pose product safety concerns (whether by reducing the efficacy or posing a risk to the end user). Continue reading

The Need for Documentation

“If It Was not Documented, It Was Not Done”

Reviewed and updated July 2020.

At one time there were three monkeys locked in a room. This room also contained a banana, suspended by a cord from the ceiling in the centre of the room. Whenever one of the monkeys grabbed the banana, all the monkeys were subjected to an icy cold shower. After several repetitions of this shower, no monkey in the room would touch the banana. Continue reading