Recent Advances in Pharmaceutical Regulations for Viable Environmental Monitoring
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.
Regulations provide specifications for the selection of an effective air monitoring strategy, both directly and indirectly. With the introduction of modern manufacturing concepts and an increasing number of industry standards, there is a need to adopt viable air monitoring in conjunction with the most recent regulatory trends.
Viable air monitoring is a crucial part of an environmental monitoring program in pharmaceutical manufacturing. The absence of microbial contamination is considered a critical quality attribute due to its potential to dramatically impact the safety and/or the efficacy of the drug product. It has been many years since common viable air monitoring methodologies have been introduced and become standard, and it is well documented that traditional methods lack sensitivity. Singular results only provide an indicator of cleanroom status, and very often no direct correlation between number of organisms and product contamination risks are found (Saghee et al., 2011).