Digitalization and Automation of the Environmental Monitoring Process in C&GT Manufacturing GMP Facilities : Solution to Leverage QC Operational Efficiency, Compliance and Optimize Resources Allocation

Microbial Environmental Monitoring (EM) is crucial to assure patient safety. The visual end point reading of petri dishes has been used for decades without a true performance assessment. Besides, there is growing interest in EM automation technologies.

In today’s pharmaceutical industry, there is myriad and high volume of GMP data being generated in the field of EM. This is a challenge, considering the increasing demands to perform further additional testing. The latest regulations are emphazing the requirement for improved data integrity to ensure that facilities are maintained in a state of GMP compliance. Data integrity is not restricted to electronic records and electronic signatures (as described in CFR 21 Part 11); it should be considered as a holistic and consistent approach, taking into account the role of people, processes, and technologies. We will explore data integrity principles and discuss how automation and digitalization of the EM process allows a facility to i). better oversee the quality control process, ii). decrease the numbers and length of investigations, iii). eliminate low value, manual, error-prone tasks and iv). increase the confidence of regulatory agencies in the facility’s quality systems.