Leveraging PAT for environmental monitoring in light of Annex 1

The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical University of Denmark and Novo Nordisk delves into advances in rapid and automated environmental monitoring systems.

The section on environmental monitoring (EM) in Annex 1 states that “The adoption of suitable rapid or automated monitoring systems should be considered by manufacturers in order to expedite the detection of microbiological contamination issues and to reduce the risk to product”.1 This article therefore considers some of the possible systems that can be applied in EM. Rapid or automated monitoring of microbiological contamination falls under US Food and Drug Administration’s (FDA’s) definition of process analytical technologies (PAT), ie, timely measurements of critical quality attributes.2

The most obvious advantage of PAT for environmental monitoring is the ability to greatly increase the frequency of monitoring. Timely measurements during processes enable faster detection of possible contamination, which can also aid diagnosis of the contamination. Current approaches for EM include a combination of settle plates, volumetric air sampling, and glove, gown and surface sampling.