Knowledge Category: Regulatory

This document discusses the current regulatory standards for viable environmental monitoring (EM) in the pharmaceutical industry. Updates to the European Union (EU) Good Manufacturing Practice (GMP) Annex 1 are analyzed to better understand the industry’s future trends and possible changes in other guidances.
Originally published for ISCC 2018 Netherlands.

A quality risk management (QRM) approach provides a holistic way to manage EM risks in a facility. Locations, sampled during room/equipment qualification, are evaluated during a risk assessment to identify the areas at greatest risk of introducing particulate or microbial contamination. Once these areas are identified, risk reduction activities can be conducted to concentrate sampling at those high-risk locations.

Stem cell therapy sterility assurance is becoming more important in the pharmaceutical industry. The genetic manipulations of the cells involved create a powerful tool to treat serious diseases, such as cancer. In 2017, the Food and Drug Administration (FDA) made several advancements towards the regulation of stem cell therapy,,,

Microbial environmental monitoring is a growing challenge for the pharmaceutical industry in an increasingly digitized industry. Manufacturers must be able to guarantee their blend of automated and operational processes are under statistical control while ensuring their data is secure and accurate. With the improvements made to other areas of production, there is a growing need for modern solutions to environmental monitoring and microbial data collection in critical areas.