Whitepaper: Recent advances in pharmaceutical regulations for viable environmental monitoring
Regulations provide specifications for the selection of an effective air monitoring strategy, both directly and indirectly.
With the introduction of modern manufacturing concepts and 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.